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Tag: impurity profiling

Mutagenic-Impurities-Risk-Assessment-Under-ICH-M7

Mutagenic Impurities Risk Assessment Under ICH M7

In pharmaceutical manufacturing the mutagenic impurities are among the most critical safety concerns. These impurities are responsible for the damage
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Understanding ICH Q3C: Residual Solvents in APIs Explained

Understanding ICH Q3C: Residual Solvents in APIs Explained

The International Council for Harmonisation (ICH) provides clear guidelines for the solvents' impurities in Active Pharmaceutical Ingredients (APIs).
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ICH Q3A vs Q3B: API and Drug Product Impurity Guidelines Explained

This comprehensive guide explains how industry professionals can benefit from the ICH Q3A and Q3B guidelines for API and drug
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Structure Elucidation of Unknown Impurity using LC MS in Pharmaceuticals

Structure Elucidation of Unknown Impurity using LC-MS/MS

Impurity analysis in pharmaceuticals is a critical quality control measure. Impurities, arising during synthesis, storage, or handling, can significantly affect
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Importance of Impurity Profiling in drug development

Impurity Profiling

Impurity profiling plays a crucial role in pharmaceutical product development and quality control. It involves the identification, quantification, and characterization
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Controlling Nitrosamine Impurities

The nitrosamines may occur in very small quantities in some drugs but they are a potential carcinogen...
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