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

Abstract：

:Regulations alarmed the control of genotoxic impurities in drug substances at lower level based on the threshold of toxicological concern and daily dose. This review explores the details of various regulations and guidances, toxicology assessment, identification of structural alerts, synthetic origins, different synthetic approaches for elimination or control, various analytical determination strategies and pharmaceutical industry concern towards genotoxic impurities.

journal_name

J Pharm Biomed Anal

journal_title

Journal of pharmaceutical and biomedical analysis

authors

Raman NV,Prasad AV,Ratnakar Reddy K

doi

10.1016/j.jpba.2010.11.039

subject

Has Abstract

pub_date

2011-06-25 00:00:00

pages

662-7

issue

4

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(10)00682-5

journal_volume

55

pub_type

杂志文章,评审

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