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Normality

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Solubility as per Pharmacopoeia

Solubility is refers to ability of a substance (the solute) to dissolve in a solvent, forming a homogeneous solution at a specific temperature and pressure. It is a key concept in chemistry and various applications, including pharmaceuticals, where it affects the bioavailability of drugs. pharmacopoeia criteria as BP and USP Pharmacopia BP and USP key points solubility: Factors Affecting…

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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…

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Out of specification Investigation Step in pharmaceutical

Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that product safe Find the root case of OOS Minimize the reoccurrence of Lab error Avoid testing in compliance Evaluate the impact of…

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7 Impressive Ways Vitamin C Benefits Your Body

Vitamin C, also known as ascorbic acid Vitamin C is an essential for your body needs to form blood vessels, cartilage, muscle and collagen in bones. It is found sources include fresh fruits and vegetables, especially citrus fruits. Some Natural source and Other  It’s for the body to develop and function properly. Vitamin C (Ascorbic Acid) found from Fresh oranges and fresh-squeezed orange juice…

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Reinventing Reputation: One of Pharma's Biggest Challenges

Reinventing Reputation: One of Pharma’s Biggest Challenges One of the biggest challenges for the pharmaceutical industry is reinventing its reputation. This task requires converting public perception from negative or skeptical to positive and trustworthy. Key Strategies for Reinventing Reputation: 1. Transparency: Communicate research, development, and production processes to the public. 2.…

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The Role of GMP Facilities in Europe's Pharmaceutical Growth

The production of medicines is crucial to the growth of Europe’s life science sector, driving demand for manufacturing space across the continent. While R&D is vital, delivering products to market requires adherence to Good Manufacturing Practice (GMP) guidelines. Key European Hubs Certain European regions, notably Ireland, Switzerland, the Netherlands, Belgium, and Germany, are becoming key…

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The growing pharmaceutical production is poised to create a demand for European GMP facilities.

The rise in pharmaceutical production is driving increased requirements for European Good Manufacturing Practice (GMP) facilities due to several key factors: 1. Increased Demand for Medications The global pharmaceutical market is expanding due to several trends: Aging Population: Europe, in particular, has a growing elderly population that requires more medical treatments and…

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Sanofi and Regeneron update trial data, strengthening case for Dupixent in COPD

  Sanofi and Regeneron’s Dupixent appears to be closing in on an FDA nod to expand its label to chronic obstructive pulmonary disorder (COPD). Data presented Monday at the American Thoracic Society (strengthen the company’s case for an approval. (Sanofi)   At the American Thoracic Society international conference in San Diego, one of the major themes is the advance of new therapies for chronic…

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As Stelara nears patent cliff, J&J fortifies Tremfya for upcoming ulcerative colitis showdown

The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. As J&J awaits an FDA approval decision for Tremfya in ulcerative colitis (UC), the company has unveiled positive phase 3 data showing the drug works as a maintenance therapy for the disease. The IL-23 inhibitor…

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Which is best solvent between Methanol vs Acetonitrile in HPLC

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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…

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Theoretical Plates chromatography-analytical chemistry

Theoretical Plates chromatography In chromatography, theoretical plates are a fundamental concept used to assess the separation efficiency of a chromatographic column. They play a crucial role in determining the quality and effectiveness of the chromatographic separation. In this section, we will define theoretical plates, explain their significance in assessing separation efficiency, and discuss…

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21 CFR general knowledge

Which is used #chromatography and #MSC, #pharmaceutical, #mpharm, #chemistryeducation etc