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This comprehensive guide explains how industry professionals can benefit from the ICH Q3A and Q3B guidelines for API and drug product impurities.
Green chemistry is no longer optional in pharmaceutical research. It is essential because the regulatory agencies expect safer processes for chemical development. Also, the companies demand cost efficiency and cleaner reactions.
If you work in pharmaceuticals, chemistry, biotech, or regulatory affairs, you will hear two terms again and again: drug substance and drug product. They sound similar, but they mean very different things.
Impurity analysis in pharmaceuticals is a critical quality control measure. Impurities, arising during synthesis, storage, or handling, can significantly affect a drug's safety, efficacy, and stability...
Liquid Chromatography-Mass Spectrometry (LC-MS or LC/MS or LCMS) is an indispensable technology in the realm of pharmaceutical analysis...
The Nitrosamine (NA) issue, often termed the "Saga," has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade...
Welcome, fresh M.Sc. Organic Chemistry graduates! Choosing the right path is crucial as you step into the professional world...
Impurity standard materials are critical tools in pharmaceutical analysis, enabling the accurate identification, quantification, and control of impurities in drug substances and drug products...
High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique for impurity identification and quantification in the pharmaceutical industry...
Pharmaceutical impurity characterization is a critical aspect of ensuring the safety, efficacy, and quality of pharmaceutical products...
The nitrosamines may occur in very small quantities in some drugs but they are a potential carcinogen...
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