#Analytical method development hplc

[wemahesh]

Parts per million (ppm) is a way of expressing very dilute concentrations of substances

Parts per million (ppm) is a way of expressing very dilute concentrations of substances. To calculate ppm, you can use the following formulas depending on what information you have. Mass base example   volume base calculation   Practical Notes For dilute aqueous solutions, 1 ppm is roughly equal to 1 mg/L. For gaseous mixtures, 1 ppm is often taken as 1 µL of gas per liter of air. Summary PPM…

[salicylicacid-manufacturer]

Crafting Clear Skin: The Precision of Salicylic Acid Manufacturing

Salicylic acid has long been a cornerstone in skincare and pharmaceutical formulations, celebrated for its remarkable efficacy in treating acne, exfoliating the skin, and managing various dermatological conditions. As a leading ingredient in numerous products, the demand for high-quality salicylic acid is unwavering. Salicylic acid manufacturers play a crucial role in meeting this demand, employing advanced technologies, stringent quality control measures, and innovative processes to produce this essential compound. In this blog, we explore the world of salicylic acid manufacturing, highlighting its significance, processes, benefits, and why it’s a cornerstone of modern skincare and pharmaceutical solutions.

The Importance of Salicylic Acid

Salicylic acid is a beta-hydroxy acid (BHA) derived from natural sources like willow bark and wintergreen leaves or synthesized in laboratories. It is renowned for its ability to penetrate pores, exfoliate dead skin cells, and reduce inflammation, making it a powerful ingredient in acne treatments, chemical peels, and dandruff shampoos. Its keratolytic properties help to soften and shed the outer layer of skin, promoting cell turnover and revealing a smoother, clearer complexion.

For more information salicylic acid manufacturer

Advanced Manufacturing Processes

Manufacturing salicylic acid involves sophisticated chemical processes to ensure purity, potency, and safety. The most common method is the Kolbe-Schmitt reaction, which synthesizes salicylic acid from sodium phenoxide and carbon dioxide under high pressure and temperature. This method yields high-purity salicylic acid, suitable for both pharmaceutical and cosmetic applications. Manufacturers utilize advanced equipment and precise control systems to maintain optimal reaction conditions, ensuring consistent quality and yield.

Quality Control and Assurance

Quality control is paramount in salicylic acid manufacturing. Rigorous testing protocols are implemented at every stage of production, from raw material selection to final product packaging. Analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS) are used to verify the purity, potency, and stability of salicylic acid. These tests ensure that the final product meets stringent industry standards and regulatory requirements, guaranteeing safety and efficacy for consumers.

Customization and Innovation

Salicylic acid manufacturers often work closely with cosmetic and pharmaceutical companies to develop customized formulations tailored to specific product needs. Whether creating a potent acne treatment, a gentle exfoliating cleanser, or an effective dandruff shampoo, manufacturers provide expertise in optimizing salicylic acid concentrations and formulations for maximum benefit. This collaborative approach fosters innovation, resulting in new and improved products that address evolving consumer demands and dermatological advancements.

Sustainability and Ethical Practices

In response to growing environmental concerns, many salicylic acid manufacturers are adopting sustainable and ethical practices. This includes sourcing raw materials from renewable resources, minimizing waste and emissions, and implementing energy-efficient technologies. Some manufacturers are also exploring greener synthesis methods that reduce environmental impact while maintaining high-quality production standards. These efforts align with the broader industry trend toward sustainability and responsible manufacturing.

Meeting Regulatory Standards

Compliance with regulatory standards is a critical aspect of salicylic acid manufacturing. Regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) set stringent guidelines for the production and use of salicylic acid in cosmetic and pharmaceutical products. Manufacturers must adhere to Good Manufacturing Practices (GMP) and ensure their products are free from contaminants, properly labeled, and safe for consumer use. Regular audits and inspections by regulatory authorities help maintain compliance and uphold product integrity.

Future Trends and Innovations

The future of salicylic acid manufacturing is marked by continuous innovation and adaptation to emerging trends. Advances in green chemistry, biotechnology, and nanotechnology are poised to revolutionize production methods, enhancing efficiency and sustainability. Additionally, research into new applications and formulations of salicylic acid promises to expand its role in skincare and healthcare, offering consumers even more effective and versatile solutions.

Conclusion

Salicylic acid manufacturers are at the forefront of producing one of the most versatile and effective ingredients in skincare and pharmaceuticals. Through advanced manufacturing processes, stringent quality control, and a commitment to innovation and sustainability, these manufacturers ensure the consistent supply of high-quality salicylic acid. As consumer demand for effective skincare solutions continues to grow, the role of salicylic acid manufacturers remains vital, driving the development of products that promote healthier, clearer skin and improved well-being. Embrace the power of precision and discover the transformative benefits of expertly crafted salicylic acid.

[zenlesszonezero]

[global-research-report]

Driving Innovation in the High-Performance Liquid Chromatography Market

The global high-performance liquid chromatography market size is expected to reach USD 7.03 billion by 2030, registering a CAGR of 6.0% from 2025 to 2030, according to a new report by Grand View Research, Inc. Rapid growth in pharmaceutical production, stringent regulatory norms for drug purity, and increasing adoption of high-performance liquid chromatography (HPLC) techniques for diagnostics and research purposes are driving the market.

HPLC is commonly used for the assessment of drug purity on an industrial scale. It also enables characterization of molecules being explored as potential new drug candidates. Demand for the technique is anticipated to grow due to its increasing applications in ensuring consistency and determination of dosage of active pharmaceutical ingredients. Furthermore, the technique holds significance in quality control testing for assuring the fulfillment of critical quality attributes in the pharmaceutical industry.

The technique is augmenting clinical diagnostic services due to the availability of improved stationary phase alternatives and multiple channel HPLC instruments that can aid in sequential analysis of patient samples. Such attributes are desirable for low- or moderate-throughput laboratories and enable faster turnaround times. Similarly, recent developments in column technologies are increasing the efficiency of HPLC operations and are likely to fuel the market growth. For instance, the advent of>2-µm superficially porous silica particles has led to improved HPLC operations at comparatively lower back-pressure and with the use of shorter columns.

Furthermore, companies involved in the market are launching new HPLC-based analyzers and systems for capitalizing on the expanding scope of applications for the technique. For instance, in June 2021, Trivitron Healthcare launched two new HPLC analyzers, NANO H5 & NANO H110, intended for the detection of HbA1c and Hb variants in less than three minutes.

In addition, the COVID-19 pandemic has accelerated the adoption of HPLC systems for the development of new therapeutics, vaccines, and reliable diagnostic methods for the disease. Furthermore, epidemiological applications of the technique for the characterization of viral proteins are expected to gain traction due to the emerging mutations of the SARS-CoV-2 virus. These factors are anticipated to positively affect the market growth.

High-performance Liquid Chromatography Market Segment Highlights

By product, the instruments segment held the largest revenue share of 48.2% in 2024 due to the increasing dominance of integrated HPLC systems and the availability of advanced detectors.

Based on application, Clinical research applications accounted for the largest revenue share of 40.7% in 2024. This growth can be linked to the increasing scope of clinical trial activities, a rise in biopharmaceutical research and development, and a growing demand for high-throughput analytical techniques.

By end-user, pharmaceutical and biotechnology companies dominated the market and accounted for 41.9% share in 2024. Within these companies, HPLC methods are employed for various applications, including quality control, drug purity determination, characterization of drug candidates, and evaluation of the stability of active ingredients in pharmaceuticals.

The North America market dominated the overall global market and accounted for the 31.68% of revenue share in 2024.

The Asia Pacific market is experiencing the fastest growth, driven by significant innovations in healthcare infrastructure and technology.

Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.

The global spectrometry market size was estimated at USD 19.71 billion in 2024 and is expected to grow at a CAGR of 7.7% from 2025 to 2030. 

The global helicobacter pylori diagnostics market sizewas estimated at USD 698.44 million in 2024 and is expected to grow at a CAGR of 5.87% from 2025 to 2030. 

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis on the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the high-performance liquid chromatography market report based on product, application, end-use and region.

High-performance Liquid Chromatography Product Outlook (Revenue, USD Billion, 2018 - 2030)

Instruments

HPLC Systems

Pumps

Detectors

Others

Consumables & Accessories

Columns

Reverse-phase HPLC Columns

Normal-phase HPLC Columns

Ion Exchange HPLC Columns

Size Exclusion HPLC Columns

Other HPLC Columns

Filters

Vials

Tubes

Others

Software

High-performance Liquid Chromatography Application Outlook (Revenue, USD Billion, 2018 - 2030)

Clinical Research Applications

Diagnostic Applications

Forensic Applications

Other Applications

High-performance Liquid Chromatography End-use Outlook (Revenue, USD Billion, 2018 - 2030)

Pharmaceutical & Biotechnology Companies

Academic & Research Institutions

Others

High-performance Liquid Chromatography Regional Outlook (Revenue, USD Billion, 2018 - 2030)

North America

US

Canada

Mexico

Europe

UK

Germany

France

Italy

Spain

Norway

Denmark

Sweden

Asia Pacific

Japan

China

India

Australia

South Korea

Thailand

Latin America

Brazil

Argentina

Middle East & Africa

South Africa

Saudi Arabia

UAE

Kuwait

Order a free sample PDF of the High-performance Liquid Chromatography Market Intelligence Study, published by Grand View Research.

[helen0086]

Liposomes Coenzyme Q10 Quality Evaluation

Liposomes are ultra-microscopic spherical carriers that encapsulate drugs in a lipid bilayer. They exert their effect by being released through osmosis or phagocytosis by macrophages [1]. Liposomes have a variety of characteristics as drug carriers. They can encapsulate both water-soluble and fat-soluble drugs. In particular, they have attracted much attention for their ability to improve the selectivity of drugs for target organs, reduce toxicity and increase the therapeutic index.

Coenzyme Q1O (coenzyme Q1O) is a coenzyme-type biochemical drug [2, 3] that is a major component of proton transfer and electron transfer in the respiratory chain of cells of living organisms. It is an activator of cellular metabolism and respiration. Coenzyme Q1O can improve mitochondrial respiratory function, promote oxidative phosphorylation, protect the integrity of the structure of biological membranes, and has a significant anti-radiation effect and 5α-reductase inhibitory effect.

It is often used in clinical practice to assist in the treatment of coronary heart disease, hypertension, congestive heart failure and arrhythmia, and also has significant effects on photosensitivity, skin ulcers, dermatitis, bedsores, trauma and other conditions. In recent years, it has also been widely used in the treatment of hair loss, pigmentation and the elimination of wrinkles to improve the quality of life. Coenzyme Q1O liposome is a newly developed pharmaceutical preparation in this laboratory, and this experiment studied the quality evaluation method.

Materials and Methods

1. 1 Instrument and Reagents

Experiments: pHS-3TC precision digital pH meter (Shanghai Tianda Instrument Co., Ltd.); CARY-1OO UV-Visible spectrophotometer (Varian, USA); high performance liquid chromatograph (Waters, USA): 51O high pressure constant current pump, 486 variable square wave length data UV detector; SR2OOO chromatography data workstation (Shanghai Sunrui Technology Co., Ltd.); TSM ultrafine particle size analyzer (Shanghai University of Technology); FA 1OO4 electronic balance (Shanghai Tianping Instrument Factory); 8O-2 centrifugal sedimentation machine (Shanghai Surgical Instrument Factory). Coenzyme Q1O raw material (Nisshin, Japan), the reference substance is refined from the raw material, purity 99.98%; Coenzyme Q1O liposome (homemade); blank liposome (homemade); anhydrous ethanol (China Pharmaceutical Group Shanghai Chemical Reagent Company); water is deionized distilled water; the remaining reagents are analytically pure.

2 pH Value Inspection

According to the 2OOO edition of the Pharmacopoeia of the People's Republic of China, Appendix VI H, a glass electrode is used as the indicator electrode and an acidimeter is used for measurement.

1. 3 Morphological Observation and Particle Size Distribution Measurement

Coenzyme Q1O liposomes were taken, stained with a negative staining method, and the morphology of the particles was observed under a transmission electron microscope; the particle size distribution was determined using a TMS ultrafine particle size analyzer.

1.4 Determination of Coenzyme Q1O Content by RP-HPLC

1. 4. 1 Chromatographic Conditions

DABC18RPODS column (15Omm× 4. 6 mm , 1Oμm, Shanghai Yiqi Technology Co., Ltd.); mobile phase: anhydrous ethanol; flow rate: 1. Oml/min; ultraviolet detection wavelength: 275nm, sensitivity: 0. O5 AuFS, injection volume 1Oμl, external standard method for quantification.

1.4. 2 Standard Curve and Detection Limit

A series of coenzyme Q1O solutions were prepared with anhydrous ethanol to give mass concentrations of 1. O, 2. O, 4. O, 8. O, and 16. O μg/ml, and detected by RP-HPLC.

1. 4. 3 Precision of the Method

Coenzyme Q1O standard solutions of 1. O, 2. O, 4. O, 8. O, and 16. O μg/ml were prepared, and the measurements were repeated 5 times within the day and between days.

4. 4 Sample Addition Recovery

Take an appropriate amount of empty liposomes, place them in a 1Oml volumetric flask, and measure precisely 25ml of coenzyme Q1O stock solution (O. 1g/ml) each. Shake well and determine the content according to the sample analysis method.

1. 4. 5 Sample Determination

Measure accurately an appropriate amount of coenzyme Q1O liposome, place it in a 1Oml volumetric flask, make up to the mark with absolute ethanol, shake well, and then dilute 1OO times with absolute ethanol. Shake well to obtain the test solution. Measure accurately 1Oμl of the test solution and inject it. Calculate the content of the test solution from the standard curve.

5 Determination of the Encapsulation Rate of Liposomes Coenzyme Q1

Dilute coenzyme Q1O liposomes 20 times with phosphate buffer (pH 7.4), measure an appropriate amount and place it in a centrifugal ultrafilter with a molecular weight cut-off of 5OOOO. Centrifuge at 3OOOr/min for 1O min to obtain a clear centrifugal liquid. Centrifuge the solution carefully, take an appropriate amount of the supernatant, dissolve it in anhydrous ethanol and make up to the mark. Shake well to obtain the test solution. Centrifuge a precise amount of 10 μl of the solution and calculate the free coenzyme Q10 content from the standard curve. Calculate the drug encapsulation rate according to the following formula:

where Wtotal and Wfree represent the total drug content and the free drug content in the liposome, respectively.

2 Results

1 Main Characteristics of Liposomes Coenzyme Q1O

Coenzyme Q1O liposomes are a pale yellow emulsion with a pH of 5. O~7. 5. They are mainly composed of unilamellar liposomes and a small amount of multilamellar liposomes. The particle sizes are relatively uniform and they are a colloidal colloidal dispersion; the particle size is basically normally distributed, with an average particle size of 0.184 μm and particles > 1 μm accounting for 0.17%.

2. 2 Results of RP-HPLC Analysis

2. 2. 1 Standard Curve Regression of Peak Area (A) Against Concentration (C) Gives the Standard Curve:

C= 6. 974× 1O— 5A—5. 894× 1O— 2, r = O. 9999(n=5)

The results show that the concentration in the range of 1. O~16. Oμg/ml has a good linear relationship with the peak area. The lowest detectable concentration of the method is 0. 1μg/ml, the lowest detection limit is 1ng, the retention time of coenzyme Q1O is about 4. 4min, and the theoretical plate number is more than 3OOO.

2. 2 Method Precision and Recovery

Intraday and interday RSD<2%. The average recovery rate was (1OO. 5±O. 65)%, n = 3.

2.2. 3 Sample Measurement Results

Three batches of samples were measured, and the coenzyme Q1O content in coenzyme Q1O liposomes was 94. 71%, 1O3.46% and 91. O9% of the labeled amount, respectively, all within the range of 9O. O%~11O. O% specified in the quality standard.

2.3 Encapsulation Rate of Liposomes Coenzyme Q10 

The encapsulation rate of three batches of coenzyme Q1O liposome samples was measured, and the encapsulation rate was >95%, which meets the requirements of liposome quality control.

3 Discussion

At present, the main methods used at home and abroad for ultrafine particle size analysis include optical microscopy, light transmission, laser scattering, and specific gravity methods. The TSM ultrafine particle size analyzer used in this experiment is a new type of particle size analyzer based on the principle of total light scattering [4]. It is used to measure the size distribution of ultrafine particles to meet the requirements of particle detection and size analysis.

A solution of coenzyme Q1O in absolute ethanol of a certain concentration was scanned with UV light in the wavelength range of 19O~ 35Onm. It was shown that coenzyme Q1O has a large absorption at 2O4, 275nm. Since there is interference in the measurement at 2O4nm, 275 nm was selected as the measurement wavelength in this experiment.

Literature reports [1] that there are many methods for determining the encapsulation rate, mainly including the dextran gel filtration method, ultracentrifugation method, dialysis method, etc. The dextran gel filtration method is a classic determination method, but it is cumbersome, time-consuming, and the raw materials are also more expensive; the ultracentrifugation method requires high instrument conditions and is expensive; the dialysis method requires continuous replacement of the dialysis solution. In this experiment, a centrifugal ultrafilter was used to determine the encapsulation rate. Coenzyme Q1O phosphate buffer can completely pass through the filter membrane. This method is convenient, fast, easy to operate, and has good reproducibility, making it more suitable for quality control in the production process.

Coenzyme Q10 is easily decomposed by light. Formulating it as a liposome preparation can improve the stability of the drug and prolong its duration of action. In addition, liposomes are hydrophilic carriers composed of phospholipid bilayers, which can also increase the compatibility of coenzyme Q10 with other hydrophilic components and increase its absorption in the body.

References:

[1] Gao Shen, ed. New dosage forms and technologies for modern drugs [M]. Beijing: People's Military Medical Publishing House, 2OO2. 197-228.

[2] Greenberg S, Frishman WH. Coenzyme Q1O: a new drug for cardiovascular disease [J]. J Clin Pharmacol, 199O, 3O(7) : 596- 6O8.

[3] Hoppe U, Bergemann j , Diembeck W , et al. Coenzyme Q1O, a cutaneous antioxidant and energizer[j]. Biofactors, 1999, 9(2- 4): 371-378.

[4] Cai XS. Measurement of particle size distribution with light extinction method [J]. Guangxue xuebao (Acta optica sin), 1991, 11(11): 49-53.

[credenceresearchdotblog]

The Chromatography Resins Market is projected to grow from USD 2,645.5 million in 2024 to approximately USD 4,345.51 million by 2032, at a compound annual growth rate (CAGR) of 6.40%. The chromatography resins market has grown significantly in recent years, with applications expanding across pharmaceutical, biotechnology, food, and environmental sectors. Chromatography, a versatile and essential analytical technique, separates compounds in complex mixtures and purifies valuable compounds. Resins, as the critical stationary phase in chromatography, are fundamental to separation processes, making chromatography resins a vital component across industries. The increasing demand for high-purity compounds, especially in drug development, and stringent regulatory standards are fueling market growth.

Browse the full report https://www.credenceresearch.com/report/chromatography-resins-market

Market Overview

The global chromatography resins market has demonstrated substantial growth due to increasing demand from biopharmaceuticals and bioprocessing industries. With applications across ion exchange, affinity, size exclusion, and hydrophobic interaction chromatography, resins serve a pivotal role in both qualitative and quantitative analyses. The global market size for chromatography resins was valued at approximately $2.1 billion in 2023, and it is projected to witness a steady growth rate over the next five years. Key factors driving this growth include the expansion of the pharmaceutical industry, especially in biologics, and rising demand for therapeutic antibodies and vaccines.

Key Drivers

1. Expansion in Pharmaceutical and Biotechnology Sectors Pharmaceutical and biotechnology companies are major consumers of chromatography resins, especially for drug development and production. Chromatography is critical in purifying and analyzing biologics like monoclonal antibodies, gene therapies, and vaccines, requiring high-purity resins to ensure efficacy and safety. With the rise in chronic diseases and the demand for innovative biologic drugs, biopharmaceutical companies are investing heavily in high-quality resin materials for efficient separation and purification.

2. Technological Advancements in Chromatography Techniques Continuous advancements in chromatography techniques, including high-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC), have heightened the demand for specialized resins. Enhanced technologies improve the efficiency, speed, and precision of separation, and these innovations are creating new avenues in industries like healthcare and environmental science. Additionally, automation and integration of artificial intelligence (AI) in chromatography are expected to bolster market growth by optimizing processes.

3. Growth in Environmental Testing and Food & Beverage Analysis Environmental and food safety regulations are becoming stricter globally, leading to increased demand for chromatography resins in testing applications. The detection of contaminants, such as pesticides and heavy metals, requires precise chromatography methods. Chromatography resins help achieve reliable and consistent results, making them critical in these sectors. With the rise in consumer demand for food safety and environmental protection, chromatography resins are increasingly utilized in these applications.

Regional Insights

The chromatography resins market shows significant growth potential across different regions, with North America currently holding a substantial share. This dominance is attributed to a strong pharmaceutical and biopharmaceutical presence, stringent regulations, and advanced healthcare infrastructure. Europe follows closely, driven by high regulatory standards and investments in biotechnological research. The Asia-Pacific region, led by China and India, is expected to witness the fastest growth due to expanding pharmaceutical production, increasing government investment in healthcare, and growing food safety concerns.

Competitive Landscape

Major players in the chromatography resins market include GE Healthcare, Merck KGaA, Bio-Rad Laboratories, and Thermo Fisher Scientific. These companies focus on R&D to develop innovative resins that offer higher efficiency and sustainability. Additionally, strategic collaborations, acquisitions, and product expansions are common approaches among industry leaders to enhance their market position.

Future Outlook and Challenges

While the chromatography resins market holds promising growth potential, it faces some challenges. High production costs, complex manufacturing processes, and strict regulations can limit smaller companies' ability to compete. However, the rise in personalized medicine, increasing demand for high-purity biomolecules, and the continuous development of next-generation chromatography technologies present significant growth opportunities. The market is anticipated to grow as demand for faster, more efficient, and environmentally friendly resins increases.

Key Player Analysis:

GE Healthcare (Cytiva)

Merck KGaA

Bio-Rad Laboratories, Inc.

Thermo Fisher Scientific, Inc.

Tosoh Corporation

Purolite Corporation

Avantor, Inc.

Pall Corporation (Danaher)

Repligen Corporation

Mitsubishi Chemical Corporation

Segmentations:

By Technique

Hydrophobic Interaction

Ion Exchange

Multi-Modal/Mixed Mode

Affinity

Size Exclusion

Others

By Type

Synthetic Polymers

Natural Polymers

Inorganic Media

By Application

Food & Beverage

Pharmaceutical & Biotechnology

Water & Environmental Analysis

Others

By Region

North America

US

Canada

Mexico

Europe

Germany

France

UK

Italy

Spain

Rest of Europe

Asia Pacific

China

Japan

India

South Korea

South-east Asia

Rest of Asia Pacific

Latin America

Brazil

Argentina

Rest of Latin America

Middle East & Africa

GCC Countries

South Africa

Browse the full report https://www.credenceresearch.com/report/chromatography-resins-market

Contact:

Credence Research

Please contact us at +91 6232 49 3207

Email: sales@credenceresearch.com

Website: www.credenceresearch.com 

[sudheervanguri]

Intas Pharmaceuticals career opportunities in Quality Control (FG/Stability/AMV) and Microbiology. With a global presence in over 85 countries, Intas Pharmaceuticals continues to grow rapidly and offers a dynamic work environment with excellent career prospects. The company is seeking professionals with relevant qualifications and experience to work at its SEZ facility in Ahmedabad. About Intas Pharmaceuticals Intas is a multinational pharmaceutical company focused on the development, manufacturing, and marketing of pharmaceutical formulations across the globe. The company has a strong foothold in the highly regulated markets of the US and EU and is recognized for its commitment to innovation, quality, and patient care. At Intas, employees are provided with a platform to contribute to global healthcare advancements while growing in their professional careers. Location: Intas Pharmaceuticals Limited, Pharmez SEZ, Ahmedabad Walk-In Date: 16th October 2024 Interview Time: 09:00 AM to 12:00 PM Venue: Plot no. 05 to 14, Pharmez, Near Village Matoda, Sarkhej - Bavla Highway 8-A, Taluka- Sanand, Dist- Ahmedabad Job Openings and Key Details Intas Pharmaceuticals is looking for skilled professionals to fill the following positions in its Quality Control and Microbiology departments. 1. Quality Control (FG/Stability/AMV) – Sr. Officer to Sr. Executive Department: Quality Control (Finished Goods, Stability, AMV) Qualification: B Pharmacy, MSc, BSc Experience: 5 to 10 years Skills Required: Expertise in Finished Goods (FG), AMV, and Stability sections. Hands-on experience with analytical instruments like HPLC/GC. Familiarity with Chromeleon software. Strong understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Responsibilities: Conduct quality control tests for finished goods, ensuring adherence to regulatory requirements. Monitor and analyze stability samples and perform method validation (AMV) procedures. Operate and maintain sophisticated laboratory equipment such as HPLC and GC. Prepare reports and documentation in compliance with regulatory standards. 2. Quality Control Microbiology – Officer to Executive Department: Quality Control Microbiology Qualification: MSc (Microbiology) Experience: 2 to 7 years Skills Required: Experience in environment monitoring within a formulation facility. Proficiency in conducting microbiological tests such as sterility, BET, and MLT. Expertise in water analysis and microbiological testing in compliance with regulatory requirements (USFDA, MHRA, EU). Knowledge of GLP and GMP and readiness to work in rotational shifts. Responsibilities: Perform environmental monitoring and water analysis to ensure a sterile environment for pharmaceutical production. Conduct various microbiological tests, including sterility, BET, and microbial limit tests (MLT). Maintain compliance with international regulatory standards and follow stringent quality control protocols. Collaborate with the quality assurance team to ensure the overall safety and quality of products. [caption id="attachment_63946" align="aligncenter" width="930"] Intas Pharmaceuticals Hiring for Quality Control (FG/Stability/AMV), Microbiology[/caption] How to Prepare for the Walk-In Interview Updated resume Educational certificates (original and photocopy) Experience certificates Last three months’ salary slips Location: Intas Pharmaceuticals Limited, Pharmez SEZ, Ahmedabad Walk-In Date: 16th October 2024 Interview Time: 09:00 AM to 12:00 PM Venue: Plot no. 05 to 14, Pharmez, Near Village Matoda, Sarkhej - Bavla Highway 8-A, Taluka- Sanand, Dist- Ahmedabad

[zenlesszonezero]

[hitechtraders]

Streamlining Your Biotechnology Research with the Right Analytical Instruments

For scientists, technicians, and researchers, the right biotechnology laboratory analytical instruments can make or break your work. Whether it's analyzing DNA, RNA, or proteins, precision and accuracy are non-negotiable.

Whether you're a seasoned pro or just starting out, your biotech lab's success hinges on having the right instruments. We'll break down the core components, their functions, and how they drive reliable outcomes. Stay tuned for insights.

The Role of Analytical Chemistry in Biotechnology

The biotechnology laboratory analytical instrumentation specialist is at the heart of this complex field. High-stakes biotech research demands precision, and that's exactly what experts bring to the table when they skillfully operate and maintain the advanced instruments behind the scenes.

With experimentation comes precision - they perfect every variable, accelerating the push for medical discoveries by masterfully working with living materials.

The Critical Relationship Between Biotechnology and Analytical Chemistry

Advanced biotechnology is intricately linked with analytical chemistry. Within the realm of genetic engineering, it's paramount to check the authenticity and quality of rDNA-created products.

From start to finish, pharmaceutical development relies on analytical chemistry to meticulously track and measure the chemical footprints of their creations – plus the bits and pieces they break down into – ensuring accurate, life-changing medications.

Mass Spectrometry in Biotechnology

Imagine being able to grasp the intricate molecular architecture of biological molecules; that's precisely what mass spectrometry lets us do, thanks to its precision measurements.

First, you essentially bomb the sample with high-energy particles, and then sort the resulting ions based on their distinct mass-to-charge signatures. Proteins, peptides, lipids, and metabolites - the building blocks of life - can be scrutinized in remarkable detail using this cutting-edge technique.

Advantages of Mass Spectrometry:

High sensitivity and specificity allow for the detection and identification of molecules at very low concentrations.

Versatility in analyzing a wide range of molecular structures.

Limitations of Mass Spectrometry:

Requires specialized equipment and skilled personnel.

Sample preparation can be time-consuming and challenging.

Analysis of large molecules is often complex and difficult.

High-Performance Liquid Chromatography (HPLC)

High-performance liquid chromatography (HPLC) is another cornerstone in the toolkit of biotechnology laboratory analytical instruments.

Imagine a very precise molecular filtering system that bases its separations on the inherent characteristics of each molecule - that's essentially what this technique does, providing researchers with a precise way to disentangle complex mixtures of biological molecules.

Advantages of HPLC

High resolution and selectivity for separating complex mixtures.

Versatility in analyzing a wide range of molecular structures.

Limitations of HPLC

Requires specialized equipment and skilled personnel.

Sample preparation can be time-consuming and challenging.

Analyzing large molecules is difficult due to their complexity.

Essential Tools for Biotechnology Research

Both mass spectrometry and HPLC are invaluable for their high precision and versatility. At the end of the day, these methods have two major weak spots. First, you need a wealth of knowledge and cutting-edge equipment to even get started. Second, coaxing meaningful data from oversized molecules is no cakewalk.

Choosing the Right Biotechnology Laboratory Analytical Instruments

For those in the field of biotechnology seeking reliable and cost-effective solutions for their experiments, HiTechTrader offers a wide range of biotech-life-science lab equipment. Their instruments are designed to meet the rigorous demands of modern research, ensuring accuracy and efficiency in every experiment.

For more information about Gas Chromatography Machine and Analytical Chemistry Equipment please visit:- Hi Tech Trader

[chemicea]

FDA's Critical Guidance on Nitrosamine-Related Impurities

The FDA's critical recommendation on nitrosamine-related pollutants represents a crucial regulatory move in the pharmaceutical industry· Nitrosamines, which are recognized carcinogens, have generated considerable worry following their unexpected discovery in numerous medications· In response, the FDA issued broad guidelines to limit this risk through rigorous assessment and control methods· These rules require a thorough review of production methods, raw materials, and finished goods to ensure compliance with permissible nitrosamine impurity levels· The FDA's goal in enacting these severe requirements is to improve drug safety and maintain public trust in pharmaceutical products, ultimately protecting public health from any nitrosamine-related dangers·

Understanding Nitrosamines

Nitrosamines are a type of chemical compound formed when certain chemicals react with nitrites in acidic conditions· They are known carcinogens and have been discovered as contaminants in a wide range of medicinal medicines, including angiotensin II receptor blockers (ARBs) and ranitidine·

Detection Methods For Nitrosamine Impurities

Detecting nitrosamine contamination in pharmaceutical items is crucial for ensuring patient safety and regulatory compliance· Several detection methods are used to produce sensitive and reliable results·

1. Spectroscopic Techniques

Pharmaceutical samples are screened for nitrosamine contamination using UV-Vis and fluorescence spectroscopy· While these methods are less specific than chromatography or MS, they yield speedy preliminary results·

2. Integration into Quality Control Processes

Pharmaceutical businesses incorporate verified detection methods within their regular quality control activities· Nitrosamine levels are continuously monitored throughout the manufacturing process to maintain regulatory compliance while also protecting product quality and patient safety·

3. Chromatographic Techniques

Nitrosamines are often detected using chromatographic methods, particularly High-Performance Liquid Chromatography (HPLC) in conjunction with detectors such as UV-Vis or mass spectrometry (MS)· These methods distinguish and measure nitrosamines based on their chemical characteristics and interactions with stationary phases·

4. Mass Spectrometry (MS) Techniques

Mass spectrometry, particularly LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry), is highly sensitive and specific for identifying nitrosamines· MS detects nitrosamine-specific ions, allowing for accurate identification even at low levels·

Critical Elements of FDA Guidance

Analytical Methods and Detection

The FDA recommends that nitrosamine contaminants be detected and measured accurately· Pharmaceutical companies are advised to use sensitive analytical techniques that can detect nitrosamines at low concentrations· The guidance makes recommendations on appropriate analytical methodologies and validation standards to achieve reliable detection capabilities·

Risk Assessment and Evaluation

The FDA's advice emphasizes the significance of undertaking detailed risk assessments for potential nitrosamine production in medicinal products. This entails examining the chemical structure, manufacturing procedures, and environmental circumstances that may lead to nitrosamine production. Companies are expected to use risk-based methodologies to detect and reduce potential risks.

Control Strategies and Mitigation Measures

To prevent nitrosamine contamination, the FDA encourages the implementation of effective control measures across the drug development and manufacturing processes. This includes implementing proper controls for raw material selection, process optimization, and packaging. Companies should create strict requirements and limitations for nitrosamine impurities and monitor and verify compliance regularly.

Conclusion

The FDA's most recent guidance on nitrosamine-related contaminants presents a critical opportunity. As regulatory scrutiny grows, our complete solutions work ideally to help pharmaceutical firms achieve compliance quickly and effectively. Chemciea is well-positioned to become a trusted partner in navigating this ever-changing terrain thanks to our superior analytical technology and experienced consultation. We empower clients by implementing proactive detection and mitigation solutions that protect product integrity and consumer trust. Embrace our customized services today to stay ahead in the struggle for regulatory compliance and industry leadership.

[colinwilson11]

Ophthalmic Drugs Contract Manufacturing: An Overview Of The Rapidly Evolving

Regulatory compliances play a pivotal role in ophthalmic drugs manufacturing due to stringent norms and quality standards set by regulatory bodies like US FDA, EMA, etc. Ophthalmic products manufacturing needs to adhere to Current Good Manufacturing Practices (CGMP) to ensure product safety, efficacy, and quality. Ophthalmic drugs contract manufacturers invest heavily in approvals, certifications, and manufacturing facilities upgradation to meet evolving regulatory guidelines. They focus on establishing robust quality management systems, validation protocols, change control systems, and document controls. Regular product quality reviews and internal audits also help contract manufacturers deliver regulatory compliance.

Leading Technology And Specialized Equipment

Ophthalmic drugs require highly sophisticated and precise manufacturing technologies and equipment due to small volumes and concentrations. Contract manufacturers leverage leading technologies like microprocessing, microfluidics, micro-molding, and precision coating to produce a diverse range of ophthalmic products. They invest in specialized, high-end equipment like micronizing mills, soft-gel encapsulation systems, and laser-marking machines. Automation and digitization using IoT, AI, and analytics also help boost production efficiency and quality. The technologies and equipment enable contract manufacturers to cater to customized packaging and dosing requirements of ophthalmic drugs.

Specialized Facilities And Cleanrooms 

Ophthalmic products demand stringent environmental control and hygiene standards owing to small dosage forms and direct exposure to eyes. Contract manufacturers operate highly specialized facilities with ISO classified cleanrooms to minimize microbial and particulate contaminations. Features like laminar air flow, differential air pressures, high-efficiency particulate air (HEPA) filtration help maintain critical environmental conditions. Periodic qualification and calibration of facilities and utility systems also ensure process validation. Designated areas for raw material receipts, products manufacturing, quality testing, packaging, and warehousing follow zoning principles. These specialized facilities enable contract manufacturers to ensure sterility, stability, and preserved efficacy of Ophthalmic Drugs Contract Manufacturing and storage.

Capabilities In Sterile Fill/Finish

A major portion of ophthalmic drugs require sterile fill/finish due to direct administration into eyes. Contract manufacturers have dedicated sterile suites equipped with barrier isolators, aseptic processing equipment, and self-contained environmental control systems. Technologies like lyophilization and terminal sterilization aid microbial decontamination. Stringent personnel training on garbing and cross-transfer procedures helps avoid contamination risks. Regular media fills and endotoxin challenge simulations validate sterilization process efficacy. Quality control testing through rapid microbiological methods, particulate testing and endotoxin assays ensure sterility assurance of aseptically filled ophthalmic products. These capabilities enable outsourcing of sterile fill/finish operations for preservative-free ophthalmic drugs.

Specialized Analytical Testing 

Ophthalmic drugs require meticulous analytical characterization and quality testing due to small amounts administered near eye region. Contract manufacturers invest in -leading analytical instruments like HPLC, GC, dissolution testing equipment, and particle size analyzers. Methods involve testing of identity, purity, content uniformity, particulate matters, pH, osmolarity, sterility, bacterial endotoxin, and preservative content. Stability indicating methods help real-time product monitoring on storage. Various ophthalmic dosage forms like ointments, gels, suspensions etc. also require formulations development and evaluation of rheological properties, spreadability and bioavailability. Contract testing laboratories employ highly trained analytical experts, validated methods and computerized data integrity systems. These specialized testing capabilities help ensure efficacy and safety of outsourced ophthalmic products.

Case Studies And Fill-Finish Agreement 

A leading UK-based ophthalmic drug firm outsourced development and fill-finish operations of its novel anti-inflammatory eye drop to a US-based contract manufacturer. Impressed by proven sterile fill/finish capabilities, quality systems, and regulatory compliance track record, six-month technology transfer was completed on schedule. Further, a 1-year commercial supply agreement was signed with production scale-up clauses. Another Ophthalmic Drugs Contract Manufacturing giant outsourced manufacturing of its portable multi-dose ophthalmic dispensers to a reputed Japanese contract manufacturer specializing in medical-device moulding. Leveraging expertise in micro-molding and precision assembly, the firm ensured precise dosing and improved patients' compliance. These cases illustrate effective collaborations aiding faster access of critical ophthalmic therapies. 

Get more insights on this topic: https://www.trendingwebwire.com/ophthalmic-drugs-contract-manufacturing-meeting-global-ophthalmic-medications-demands-through-specialized-services/

About Author:

Priya Pandey is a dynamic and passionate editor with over three years of expertise in content editing and proofreading. Holding a bachelor's degree in biotechnology, Priya has a knack for making the content engaging. Her diverse portfolio includes editing documents across different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. Priya's meticulous attention to detail and commitment to excellence make her an invaluable asset in the world of content creation and refinement. (LinkedIn - https://www.linkedin.com/in/priya-pandey-8417a8173/)

*Note: 1. Source: Coherent Market Insights, Public sources, Desk research 2. We have leveraged AI tools to mine information and compile it

[inscinstech]

Exploring Liquid Chromatography in Oligonucleotide Synthesis

In the intricate field of biotechnology and molecular research, liquid chromatography plays a pivotal role in ensuring the precision and quality of synthesized oligonucleotides. Oligonucleotides, short chains of nucleotides, are essential components in various biological and medical applications. From genetic research to treatments, their purity is paramount. As the demand for custom-designed oligonucleotides increases, so does the need for advanced purification techniques, with liquid chromatography emerging as a key tool in this process.

The Role of Liquid-Chromatography in Biotechnology:

Liquid-chromatography, particularly high-performance liquid-chromatography (HPLC), has long been recognized as a vital analytical tool in biochemistry. It separates compounds in a mixture based on their chemical properties, allowing researchers to isolate specific molecules. When applied to oligonucleotide synthesis, HPLC offers an efficient way to purify these molecules, ensuring that only the desired sequences are obtained.

During synthesis, impurities such as truncated sequences or incomplete chains can accumulate, reducing the overall quality of the product. By employing liquid-chromatography, these impurities are separated from the full-length oligonucleotides, resulting in highly pure samples ready for further use in scientific research or medical applications.

Oligonucleotide Synthesis: A Key Biotechnological Process

Oligonucleotide synthesis involves the chemical creation of short nucleotide chains, which can be tailored to specific sequences. These sequences are used in a variety of ways, from gene editing technologies like CRISPR to diagnostics and therapeutic applications. The precision with which these sequences are constructed is essential, and thus, purification using liquid-chromatography becomes a crucial step.

Given the complexities involved in oligonucleotide synthesis, ensuring purity is not only important for functionality but also for regulatory compliance. Impurities can affect the results of experiments or treatments, making reliable purification techniques such as HPLC indispensable in the workflow of synthesis.

Liquid-Chromatography Enhances Oligonucleotide Research:

In oligonucleotide research, the need for high-purity samples is a constant challenge. Liquid-chromatography, with its ability to differentiate between molecules of varying sizes and properties, ensures that only the required oligonucleotides are isolated. This capability has expanded the potential for discoveries in fields such as genomics, molecular biology, and drug development. With precise purification methods, many of these advancements are possible.

Moreover, the application of liquid-chromatography in oligonucleotide synthesis allows researchers to scale up production while maintaining consistency in quality. As synthetic oligonucleotides are increasingly being used in therapies, diagnostics, and gene editing, reliable purification techniques like HPLC are vital to advancing this rapidly evolving field.

Conclusion:

As biotechnology continues to evolve, the importance of liquid chromatography in oligonucleotide synthesis remains undeniable. Its ability to provide the necessary purification for these delicate molecules ensures that scientific research and medical treatments can proceed with precision and confidence. For more information on how liquid chromatography can optimize your oligonucleotide processes, visit inscinstech.com.cn for innovative solutions.

[zenlesszonezero]

[wemahesh]

analytical method validation for pharmaceutical quality control

Type of analytical procedure validated Identification tests. Quantitative tests for impurities’ content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product Type analytical method validation   1. Identification tests. Identification  First Parameter show Identification…

[best-testing-lab-uae]

How Advanced Technologies are Revolutionizing Drinking Water Testing in Dubai | +971 554747210

As Dubai continues to grow into a global hub of innovation and development, the need for ensuring safe and clean drinking water has never been more crucial. Drinking Water Testing plays a pivotal role in safeguarding public health by identifying and addressing potential contaminants. With the rapid advancement of technology, the methods used in drinking water testing are evolving, bringing more precision, efficiency, and reliability. In this blog, we explore how advanced technologies are revolutionizing drinking water testing in Dubai and enhancing the quality and safety of water for its residents.

The Evolution of Drinking Water Testing

Traditionally, drinking water testing involved basic chemical and microbiological analysis methods. While these methods were effective, they often lacked the speed and sensitivity required to address emerging contaminants and complex water quality issues. Today, advanced technologies have transformed the landscape of water testing, offering more comprehensive, accurate, and real-time solutions.

Key Technologies Revolutionizing Drinking Water Testing in Dubai

1. Polymerase Chain Reaction (PCR)

Polymerase Chain Reaction (PCR) is a groundbreaking technology that has significantly advanced microbial detection in drinking water.

How It Works: PCR amplifies specific DNA sequences from microorganisms present in water samples, allowing for the detection of pathogens even at very low concentrations.

Benefits: PCR provides high sensitivity and rapid results, which is crucial for identifying harmful bacteria, viruses, and other microorganisms that can pose health risks. This technology is essential for ensuring that water remains free from disease-causing pathogens.

2. Gas Chromatography-Mass Spectrometry (GC-MS)

Gas Chromatography-Mass Spectrometry (GC-MS) is a sophisticated analytical technique used to detect and quantify chemical contaminants in drinking water.

How It Works: GC-MS separates components of a water sample using gas chromatography, then identifies and quantifies each component based on its molecular mass through mass spectrometry.

Benefits: GC-MS offers precise and accurate measurements of chemical residues, including pesticides, industrial pollutants, and disinfection by-products. This technology ensures that water is free from harmful chemicals and meets safety standards.

3. High-Performance Liquid Chromatography (HPLC)

High-Performance Liquid Chromatography (HPLC) is employed to analyze organic compounds and contaminants in drinking water.

How It Works: HPLC passes water samples through a high-pressure liquid column, where components are separated and detected using various detectors.

Benefits: HPLC provides high resolution and precision, making it ideal for detecting trace levels of organic contaminants such as pharmaceuticals and personal care products. This technology is crucial for ensuring that water is not tainted by potentially harmful substances.

4. Real-Time Monitoring Systems

Real-Time Monitoring Systems use advanced sensors to continuously track various water quality parameters.

How It Works: Sensors measure parameters such as pH, turbidity, chlorine levels, and temperature in real time, providing ongoing feedback on water quality.

Benefits: Real-time monitoring allows for immediate detection of deviations from acceptable levels, enabling rapid response and corrective actions. This technology enhances the ability to maintain consistent water quality and address issues as they arise.

5. Nanotechnology

Nanotechnology involves the manipulation of materials at the nanoscale to enhance water purification and testing processes.

How It Works: Nanotechnology can be used to develop advanced filtration materials and sensors with enhanced capabilities for detecting and removing contaminants at very low concentrations.

Benefits: Nanotechnology improves the efficiency of water purification and testing processes, offering more effective removal of contaminants and providing more accurate testing results.

Benefits of Advanced Technologies in Drinking Water Testing

The integration of advanced technologies into drinking water testing in Dubai offers several significant benefits:

1. Enhanced Accuracy and Sensitivity

Advanced technologies like PCR and GC-MS provide highly accurate and sensitive detection of contaminants, even at trace levels. This ensures that potential risks are identified and addressed before they affect public health.

2. Faster Results

Technologies such as real-time monitoring systems and PCR offer rapid results, reducing the time needed to identify and respond to water quality issues. Faster testing enables quicker decision-making and ensures that water safety measures are implemented promptly.

3. Comprehensive Analysis

Modern technologies allow for more comprehensive analysis of drinking water, covering a wide range of contaminants, including microbial, chemical, and physical parameters. This holistic approach ensures that all potential risks are assessed and managed.

4. Improved Efficiency

Advanced methods streamline the testing process, reducing the need for manual interventions and increasing overall efficiency. Automation and high-throughput technologies enhance the lab's ability to handle large volumes of samples and deliver accurate results.

5. Real-Time Data Access

Real-time monitoring systems provide continuous data on water quality, allowing for immediate detection of issues and timely interventions. This proactive approach helps maintain consistent water quality and prevents potential problems from escalating.

The Impact on Dubai’s Water Quality Management

The adoption of advanced technologies in drinking water testing has had a profound impact on Dubai’s water quality management:

1. Enhanced Public Health Protection

By providing accurate, timely, and comprehensive testing results, advanced technologies help ensure that Dubai’s drinking water remains safe and free from contaminants. This protection is crucial for safeguarding public health and preventing waterborne diseases.

2. Compliance with Standards

Advanced testing methods help Dubai meet local and international water quality standards, including those set by the Dubai Municipality, the Abu Dhabi Quality and Conformity Council (ADQCC), and the World Health Organization (WHO). Compliance with these standards is essential for maintaining regulatory approvals and ensuring consumer safety.

3. Support for Innovation

The integration of cutting-edge technologies in drinking water testing supports Dubai’s broader goals of innovation and sustainability. It demonstrates the city’s commitment to adopting advanced solutions to address challenges and improve quality of life.

4. Efficient Resource Management

Advanced testing technologies contribute to more efficient resource management by providing accurate data on water quality and contamination levels. This information aids in optimizing water treatment processes and reducing waste.

Conclusion

In Dubai, where the demand for safe and clean drinking water is high, the revolution brought about by advanced technologies in drinking water testing is crucial. Technologies like PCR, GC-MS, HPLC, real-time monitoring systems, and nanotechnology are transforming the way water quality is monitored and managed.

These advancements offer enhanced accuracy, faster results, comprehensive analysis, improved efficiency, and real-time data access. As Dubai continues to grow and develop, these technologies play a vital role in ensuring that the city’s drinking water remains safe and of the highest quality for its residents. By embracing and leveraging these innovations, Dubai is not only safeguarding public health but also setting a global standard for excellence in water quality management.

[helen0086]

Liposomes Coenzyme Q10 Quality Evaluation

Liposomes are ultra-microscopic spherical carriers that encapsulate drugs in a lipid bilayer. They exert their effect by being released through osmosis or phagocytosis by macrophages [1]. Liposomes have a variety of characteristics as drug carriers. They can encapsulate both water-soluble and fat-soluble drugs. In particular, they have attracted much attention for their ability to improve the selectivity of drugs for target organs, reduce toxicity and increase the therapeutic index.

Coenzyme Q1O (coenzyme Q1O) is a coenzyme-type biochemical drug [2, 3] that is a major component of proton transfer and electron transfer in the respiratory chain of cells of living organisms. It is an activator of cellular metabolism and respiration. Coenzyme Q1O can improve mitochondrial respiratory function, promote oxidative phosphorylation, protect the integrity of the structure of biological membranes, and has a significant anti-radiation effect and 5α-reductase inhibitory effect.

It is often used in clinical practice to assist in the treatment of coronary heart disease, hypertension, congestive heart failure and arrhythmia, and also has significant effects on photosensitivity, skin ulcers, dermatitis, bedsores, trauma and other conditions. In recent years, it has also been widely used in the treatment of hair loss, pigmentation and the elimination of wrinkles to improve the quality of life. Coenzyme Q1O liposome is a newly developed pharmaceutical preparation in this laboratory, and this experiment studied the quality evaluation method.

1.Materials and Methods

1. 1  Instruments and Reagents

Experiments: pHS-3TC precision digital pH meter (Shanghai Tianda Instrument Co., Ltd.); CARY-1OO UV-Visible spectrophotometer (Varian, USA); high performance liquid chromatograph (Waters, USA): 51O high pressure constant current pump, 486 variable square wave length data UV detector; SR2OOO chromatography data workstation (Shanghai Sunrui Technology Co., Ltd.); TSM ultrafine particle size analyzer (Shanghai University of Technology); FA 1OO4 electronic balance (Shanghai Tianping Instrument Factory); 8O-2 centrifugal sedimentation machine (Shanghai Surgical Instrument Factory). Coenzyme Q1O raw material (Nisshin, Japan), the reference substance is refined from the raw material, purity 99.98%; Coenzyme Q1O liposome (homemade); blank liposome (homemade); anhydrous ethanol (China Pharmaceutical Group Shanghai Chemical Reagent Company); water is deionized distilled water; the remaining reagents are analytically pure.

2 pH Value Inspection

According to the 2OOO edition of the Pharmacopoeia of the People's Republic of China, Appendix VI H, a glass electrode is used as the indicator electrode and an acidimeter is used for measurement.

1. 3 Morphological Observation and Particle Size Distribution Measurement

Coenzyme Q1O liposomes were taken, stained with a negative staining method, and the morphology of the particles was observed under a transmission electron microscope; the particle size distribution was determined using a TMS ultrafine particle size analyzer.

1.4 Determination of Coenzyme Q1O Content by RP-HPLC

1. 4. 1 Chromatographic Conditions

DABC18RPODS column (15Omm× 4. 6 mm , 1Oμm, Shanghai Yiqi Technology Co., Ltd.); mobile phase: anhydrous ethanol; flow rate: 1. Oml/min; ultraviolet detection wavelength: 275nm, sensitivity: 0. O5 AuFS, injection volume 1Oμl, external standard method for quantification.

1.4. 2 Standard Curve and Detection Limit

A series of coenzyme Q1O solutions were prepared with anhydrous ethanol to give mass concentrations of 1. O, 2. O, 4. O, 8. O, and 16. O μg/ml, and detected by RP-HPLC.

1. 4. 3 Precision of the Method

Coenzyme Q1O standard solutions of 1. O, 2. O, 4. O, 8. O, and 16. O μg/ml were prepared, and the measurements were repeated 5 times within the day and between days.

4. 4 Sample Addition Recovery

Take an appropriate amount of empty liposomes, place them in a 1Oml volumetric flask, and measure precisely 25ml of coenzyme Q1O stock solution (O. 1g/ml) each. Shake well and determine the content according to the sample analysis method.

1. 4. 5 Sample Determination

Measure accurately an appropriate amount of coenzyme Q1O liposome, place it in a 1Oml volumetric flask, make up to the mark with absolute ethanol, shake well, and then dilute 1OO times with absolute ethanol. Shake well to obtain the test solution. Measure accurately 1Oμl of the test solution and inject it. Calculate the content of the test solution from the standard curve.

5 Determination of the Encapsulation Rate of Liposomes Coenzyme Q1O

Dilute coenzyme Q1O liposomes 2O times with phosphate buffer (pH 7.4), measure an appropriate amount and place it in a centrifugal ultrafilter with a molecular weight cut-off of 5OOOO. Centrifuge at 3OOOr/min for 1O min to obtain a clear centrifugal liquid. Centrifuge the solution carefully, take an appropriate amount of the supernatant, dissolve it in anhydrous ethanol and make up to the mark. Shake well to obtain the test solution. Centrifuge a precise amount of 10 μl of the solution and calculate the free coenzyme Q10 content from the standard curve. Calculate the drug encapsulation rate according to the following formula:

where Wtotal and Wfree represent the total drug content and the free drug content in the liposome, respectively.

2 Results

1 Main Characteristics of Liposomes Coenzyme Q1O

Coenzyme Q1O liposomes are a pale yellow emulsion with a pH of 5. O~7. 5. They are mainly composed of unilamellar liposomes and a small amount of multilamellar liposomes. The particle sizes are relatively uniform and they are a colloidal colloidal dispersion; the particle size is basically normally distributed, with an average particle size of 0.184 μm and particles > 1 μm accounting for 0.17%.

2. 2 Results of RP-HPLC Analysis

2. 2. 1 Standard Curve Regression of Peak Area (A) Against Concentration (C) Gives the Standard Curve:

C= 6. 974× 1O— 5A—5. 894× 1O— 2, r = O. 9999(n=5)

The results show that the concentration in the range of 1. O~16. Oμg/ml has a good linear relationship with the peak area. The lowest detectable concentration of the method is 0. 1μg/ml, the lowest detection limit is 1ng, the retention time of coenzyme Q1O is about 4. 4min, and the theoretical plate number is more than 3OOO.

2. 2 Method Precision and Recovery

Intraday and interday RSD<2%. The average recovery rate was (1OO. 5±O. 65)%, n = 3.

2.2. 3 Sample Measurement Results

Three batches of samples were measured, and the coenzyme Q1O content in coenzyme Q1O liposomes was 94. 71%, 1O3.46% and 91. O9% of the labeled amount, respectively, all within the range of 9O. O%~11O. O% specified in the quality standard.

2.3 Encapsulation Rate of Liposomes Coenzyme Q10 

The encapsulation rate of three batches of coenzyme Q1O liposome samples was measured, and the encapsulation rate was >95%, which meets the requirements of liposome quality control.

3 Discussion

At present, the main methods used at home and abroad for ultrafine particle size analysis include optical microscopy, light transmission, laser scattering, and specific gravity methods. The TSM ultrafine particle size analyzer used in this experiment is a new type of particle size analyzer based on the principle of total light scattering [4]. It is used to measure the size distribution of ultrafine particles to meet the requirements of particle detection and size analysis.

A solution of coenzyme Q1O in absolute ethanol of a certain concentration was scanned with UV light in the wavelength range of 19O~ 35Onm. It was shown that coenzyme Q1O has a large absorption at 2O4, 275nm. Since there is interference in the measurement at 2O4nm, 275 nm was selected as the measurement wavelength in this experiment.

Literature reports [1] that there are many methods for determining the encapsulation rate, mainly including the dextran gel filtration method, ultracentrifugation method, dialysis method, etc. The dextran gel filtration method is a classic determination method, but it is cumbersome, time-consuming, and the raw materials are also more expensive; the ultracentrifugation method requires high instrument conditions and is expensive; the dialysis method requires continuous replacement of the dialysis solution. In this experiment, a centrifugal ultrafilter was used to determine the encapsulation rate. Coenzyme Q1O phosphate buffer can completely pass through the filter membrane. This method is convenient, fast, easy to operate, and has good reproducibility, making it more suitable for quality control in the production process.

Coenzyme Q10 is easily decomposed by light. Formulating it as a liposome preparation can improve the stability of the drug and prolong its duration of action. In addition, liposomes are hydrophilic carriers composed of phospholipid bilayers, which can also increase the compatibility of coenzyme Q10 with other hydrophilic components and increase its absorption in the body.

References:

[1] Gao Shen, ed. New dosage forms and technologies for modern drugs [M]. Beijing: People's Military Medical Publishing House, 2OO2. 197-228.

[2] Greenberg S, Frishman WH. Coenzyme Q1O: a new drug for cardiovascular disease [J]. J Clin Pharmacol, 199O, 3O(7) : 596- 6O8.

[3] Hoppe U, Bergemann j , Diembeck W , et al. Coenzyme Q1O, a cutaneous antioxidant and energizer[j]. Biofactors, 1999, 9(2- 4): 371-378.

[4] Cai XS. Measurement of particle size distribution with light extinction method [J]. Guangxue xuebao (Acta optica sin), 1991, 11(11): 49-53.

#CoenzymeQ10 #coenzymeQ10liposomes

[banarjeenikita]

Ensuring Quality: How Leading Manufacturers Maintain High Standards in Ramipril API Production

In the pharmaceutical industry, ensuring the quality of Active Pharmaceutical Ingredients (APIs) is paramount, as it directly affects the safety and efficacy of the final drug products. For cardiovascular medications like Ramipril, which are widely prescribed for treating hypertension and reducing the risk of heart attacks and strokes, maintaining high production standards is crucial. Leading Ramipril API manufacturers have developed stringent protocols to guarantee that their APIs meet the highest standards of quality, purity, and consistency. This article explores how these manufacturers maintain their reputation for excellence in Ramipril API production.

The Importance of Quality in API Manufacturing

The quality of the Active Pharmaceutical Ingredient (API) is the foundation of any drug’s therapeutic efficacy. A compromised API can result in subpar drug performance or even harmful side effects for patients. For Ramipril, an ACE (angiotensin-converting enzyme) inhibitor that helps manage high blood pressure and prevent cardiovascular complications, quality is non-negotiable. Poor quality or inconsistent Ramipril can lead to ineffective treatment, putting patients’ lives at risk.

Maintaining high standards in API production involves a meticulous process that requires adherence to strict regulatory guidelines, constant quality control, and ongoing improvements in production methods. For Ramipril API manufacturers, ensuring quality is a multi-step process that spans the entire production cycle—from sourcing raw materials to the final packaging of the API.

Key Quality Control Measures in Ramipril API Production

1. Sourcing High-Quality Raw Materials

The quality of the raw materials used in API production is critical to the overall quality of the final product. Leading Ramipril API manufacturers work with certified suppliers who provide raw materials that meet stringent quality requirements. Before any raw material is used in the manufacturing process, it undergoes thorough testing to ensure it meets the necessary purity, potency, and consistency standards.

The chemical precursors for Ramipril must be free of contaminants that could compromise the drug's stability or efficacy. As a result, reputable API manufacturers focus on establishing long-term partnerships with trusted suppliers, ensuring a stable supply of high-quality inputs.

2. Adherence to Good Manufacturing Practices (GMP)

One of the most important frameworks guiding pharmaceutical manufacturing is Good Manufacturing Practices (GMP), a set of guidelines that ensure drugs are produced in a clean, controlled, and consistent environment. GMP compliance is essential for Ramipril API manufacturers, as it guarantees that their production processes consistently meet international standards.

Under GMP, API manufacturers must follow strict protocols for everything from facility cleanliness to equipment maintenance and staff training. The implementation of GMP helps prevent contamination, mix-ups, and errors, ensuring that each batch of Ramipril API meets the required quality standards.

3. Advanced Analytical Testing

Throughout the manufacturing process, Ramipril API manufacturers rely on advanced analytical testing to monitor quality at every stage. Testing begins with raw materials and continues through each production step, including intermediate compounds and final products.

Common tests for Ramipril API include High-Performance Liquid Chromatography (HPLC) to assess purity, Mass Spectrometry (MS) for identifying chemical compositions, and Fourier Transform Infrared Spectroscopy (FTIR) for structural verification. These tests ensure that the API meets all critical specifications for identity, strength, purity, and stability.

4. Environmental and Process Controls

The environmental conditions in which Ramipril API is manufactured can significantly affect its quality. Temperature, humidity, and air quality must be carefully controlled to avoid contamination or degradation of the product. Leading Ramipril API manufacturers invest in state-of-the-art facilities equipped with climate control systems that maintain ideal production environments.

Process control is equally vital. Manufacturers use automated systems to monitor critical parameters like reaction times, temperatures, and pressures throughout the production process. These systems help maintain consistency and ensure that each batch of Ramipril API meets predetermined specifications.

5. Stringent Regulatory Compliance

Pharmaceutical APIs are subject to stringent regulations by authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). To remain competitive and trustworthy, Ramipril API manufacturers must comply with these regulations and frequently undergo inspections by regulatory bodies.

These inspections ensure that manufacturers follow current GMP guidelines, maintain adequate documentation, and produce APIs that meet safety and efficacy standards. Manufacturers that fail to comply with these regulations risk product recalls, fines, and reputational damage.

6. Batch Release and Stability Testing

Before any batch of Ramipril API is released for sale, it must undergo rigorous testing to confirm that it meets all quality specifications. Stability testing is particularly important, as it ensures that the API will remain effective throughout its shelf life. Ramipril API manufacturers conduct both short-term and long-term stability tests to assess how the product performs under various environmental conditions.

Conclusion

The production of high-quality Ramipril API requires precision, consistency, and adherence to strict regulatory standards. Leading Ramipril API manufacturers go to great lengths to ensure the purity, potency, and safety of their products. By carefully sourcing raw materials, following Good Manufacturing Practices, utilizing advanced analytical testing, and maintaining strict process controls, they consistently produce APIs that meet the demands of the pharmaceutical industry. For manufacturers, quality is not just a goal—it's a commitment that ensures the safety and efficacy of the medications that millions of patients rely on.

[mktgluna]

Maximizing the Benefits of Cannabinoid Potency Testing in Long Beach

In Long Beach, cannabinoid potency testing is vital for ensuring the highest quality cannabis products. As the cannabis industry continues to thrive, leveraging potency testing effectively can significantly enhance product quality and consumer satisfaction. This article explores how to maximize the benefits of cannabinoid potency testing in Long Beach for both consumers and producers.

Why Cannabinoid Potency Testing Matters

Cannabinoid potency testing measures the levels of cannabinoids such as THC (tetrahydrocannabinol) and CBD (cannabidiol) in cannabis products. Here’s why it’s crucial:

Precise Dosage Control: Cannabinoid potency testing ensures accurate measurement of THC and CBD levels, allowing consumers to receive consistent and reliable effects from their cannabis products.

Quality Assurance: Regular potency testing upholds high standards by confirming that products meet specified potency and purity levels, ensuring quality and safety.

Regulatory Compliance: In Long Beach, adherence to local regulations often requires cannabinoid potency testing. Compliance with these regulations is essential for legal market operation and avoiding fines.

The Cannabinoid Potency Testing Process

The cannabinoid potency testing process involves several key steps:

Sample Collection: Collecting representative samples from different batches is crucial for accurate potency testing. Proper collection techniques ensure reliable results.

Laboratory Analysis: Samples are analyzed in a certified laboratory using advanced methods like High-Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC). These techniques provide precise measurements of cannabinoid concentrations.

Interpreting Results: Laboratories provide detailed reports on cannabinoid levels, including THC and CBD. Understanding these results helps growers and manufacturers adjust their products to meet desired potency levels.

Product Adjustment: Based on test results, growers and manufacturers can modify their formulations or processes to achieve consistent potency and quality.

Key Benefits of Cannabinoid Potency Testing

Enhanced Consumer Trust: Accurate cannabinoid potency testing builds consumer trust by providing clear information about cannabinoid content, helping consumers make informed choices.

Consistent Product Quality: Regular potency testing ensures consistency across different product batches, which is vital for maintaining brand reputation and consumer satisfaction.

Effective Marketing: Transparent potency testing results can be used in marketing materials and product labels, attracting informed consumers and differentiating products in the competitive Long Beach market.

Optimized Product Development: Insights from cannabinoid potency testing enable growers and manufacturers to create products with specific cannabinoid profiles tailored to consumer preferences and therapeutic needs.

Selecting a Cannabinoid Potency Testing Lab in Long Beach

When choosing a cannabinoid potency testing lab in Long Beach, consider these factors:

Accreditation: Ensure the lab is accredited and adheres to industry standards for potency testing.

Reputation: Select labs known for accuracy and reliability in cannabinoid potency testing.

Technology: Choose facilities that use advanced analytical techniques like HPLC or GC for precise measurements.

Customer Service: Look for labs that offer clear guidance and comprehensive support in interpreting test results.

The Future of Cannabinoid Potency Testing

Advancements in cannabinoid potency testing technologies and methodologies are continuously evolving. Innovations in analytical techniques and regulatory standards will further improve the accuracy and reliability of potency testing in Long Beach, leading to higher-quality cannabis products.

In conclusion, cannabinoid potency testing is essential for maximizing the benefits of cannabis products in Long Beach. By accurately measuring cannabinoid concentrations, ensuring regulatory compliance, and maintaining product consistency, growers and manufacturers can enhance product quality and build consumer trust. Embracing effective potency testing practices is key to thriving in the competitive cannabis market.

[sudheervanguri]

Aurobindo Pharma Recruitment 2024 Aurobindo Pharma, a global leader in pharmaceuticals, is actively seeking experienced professionals to join their Nasal Formulation Analytical R&D team. This exciting opportunity is ideal for candidates with a background in analytical method development and validation, specifically within the nasal formulation domain. If you are looking for a challenging role in a fast-paced research environment, Aurobindo Pharma provides the perfect platform to advance your career. About Aurobindo Pharma Aurobindo Pharma is committed to improving health worldwide by delivering high-quality, affordable pharmaceutical products. With a strong presence in over 150 countries, the company leads in multiple therapeutic areas and continually pushes the boundaries of innovation in drug development and formulation. Nasal Formulation Analytical R&D Job Overview: Aurobindo Pharma is looking for qualified professionals for the position of Nasal Formulation Analytical R&D. The role is located at Aurobindo Pharma Limited Research Centre II, in Kandi Mandal, Sangareddy, Telangana. This is an excellent opportunity for individuals with extensive experience in analytical methods and formulation development to contribute to a highly impactful project in the pharmaceutical industry. Key Responsibilities of Nasal Formulation Analytical R&D: Experience in analytical method development and validation (HPLC and GC). Hands on experience in Spraytec, Spray view and cascade impaction. Trouble Shooting and independently problem-solving ability. Prepare method development and method validation protocols and reports. Maintain lab instruments as per GMP/GLC. Review of raw data and reports. Preparation of operational and Calibration SOPs. Analyse the formulation strategy, efficiency, Working relations and Cross-functional Coordination. [caption id="attachment_56779" align="aligncenter" width="930"] Aurobindo Pharma Walk-In Interview for Production, Warehouse, and Engineering[/caption] Qualifications required to apply Nasal Formulation Analytical R&D: Education: M. Pharm / M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Experience: A minimum of 3 to 8 years in analytical method development, preferably in Nasal Formulation R&D. Technical Skills: Expertise in analytical techniques like HPLC, GC, Spraytec, and Cascade Impaction. Work Location: Aurobindo Pharma Limited Research Centre II Survey No. 71 & 72, Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana - 502329, India. How to Apply for Aurobindo: Interested candidates are invited to send their CVs to venkatesh.avanigadda@aurobindo.com