Recent advances in analysis of hazardous genotoxic impurities in pharmaceuticals by HPLC, GC, and CE-Reference-Cited by-同舟云学术

Recent advances in analysis of hazardous genotoxic impurities in pharmaceuticals by HPLC, GC, and CE

Published:2016-01-02 Issue:1 Volume:39 Page:1-7
ISSN:1082-6076
Container-title:Journal of Liquid Chromatography & Related Technologies
language:en
Short-container-title:Journal of Liquid Chromatography & Related Technologies

Author:

Al Azzam Khaldun M.¹,Aboul-Enein Hassan Y.²

Affiliation:

1. Department of Pharmaceutical Chemistry, Pharmacy Program, Batterjee Medical College for Sciences and Technology (BMC), Jeddah, Kingdom of Saudi Arabia

2. Department of Pharmaceutical and Medicinal Chemistry, Pharmaceutical and Drug Industries Research Division, National Research Center, Dokki, Giza, Egypt

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Pharmaceutical Science,Biochemistry,Analytical Chemistry

Link

https://www.tandfonline.com/doi/pdf/10.1080/10826076.2015.1111794

Reference48 articles.

1. Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs)

2. Regulation of genotoxic and carcinogenic impurities in drug substances and products

3. Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective

4. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process

5. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development

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