Control and analysis of hydrazine, hydrazides and hydrazones—Genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products

Author:

Elder D.P.,Snodin D.,Teasdale A.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference59 articles.

1. Guideline on the Limits of Genotoxic Impurities,2006

2. Guidance for Industry. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches,2008

3. The control and analysis of alkyl esters of alkyl and aryl sulphonic acids in novel active pharmaceutical ingredients (APIs);Elder;J. Pharm. Biomed. Anal.,2008

4. The control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs);Elder;J. Pharm. Biomed. Anal.,2008

5. Review: analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals;Elder;J. Pharm. Biomed. Anal.,2010

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