Determination of potentially genotoxic impurities in crotamiton active pharmaceutical ingredient by gas chromatography-Reference-Cited by-同舟云学术

Determination of potentially genotoxic impurities in crotamiton active pharmaceutical ingredient by gas chromatography

Published:2022-02 Issue: Volume:210 Page:114544
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Kalauz Andrea,Kapui Imre

Publisher

Elsevier BV

Subject

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

Reference22 articles.

1. ICH Harmonisation Guideline Q3A(R2), Impurities in New Drug Substances, 2006.

2. Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199/02, 2008.

3. ICH Guideline M7 on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, 2014.

4. ICH Harmonisation Guideline M7(R1), Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, 2017.

5. Kucer, The Use of Antibiotics, M.L. Grayson (eds.), 6pp Edition, Hodder Arnold, pp. 2325–8.

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