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Chapter 7: Compound- and Class-Specific Limits for Common Impurities in Pharmaceuticals

Bercu J; Masuda-Herrera M; Trejo-Martin A; Snodin D; Cross K; Johnson, G; Harvey JS; Foster R; Ponting DJ; Williams RV;

Chapter 7 in Mutagenic Impurities: Strategies for Identification and Control - Andrew Teasdale

"In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective.

The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment.

The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination."

 

Chapter 7: Compound- and Class-Specific Limits for Common Impurities in Pharmaceuticals 

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