Impurity

Isolation and Identification of Impurities and Degradants
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Isolation and Identification of Impurities and Degradants

ByPharma Digest

The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation to prevent these impurities and degradants. Impurity and degradant structure elucidation…

Best Practices to control N-Nitrosamine Impurities
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Best Practices to control N-Nitrosamine Impurities

ByPharma Digest

N-Nitrosamine impurities are a major concern for pharmaceutical industry. Because it is regulatory requirement to control the nitrosamine impurities in human drugs. In this article we are sharing 10 best practices to control the nitrosamine impurites. Use high-quality raw materials: The quality of raw materials used in the manufacturing process plays a crucial role in…