Determination of genotoxic impurity in atazanavir sulphate drug substance by LC–MS

Author:

K. Geetha Bhavani,K. Bala Murali Krishna,N. Srinivasu,D. Ramachandran,N. V.V.S.S Raman,B. Hari Babu

Publisher

Elsevier BV

Subject

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

Reference7 articles.

1. International Conference on Harmonisation Q3A-Q3D Impurities-International Council for Harmonization guidelines.

2. Regulation of genotoxic and carcinogenic impurities in drug substances and products;McGovern;Trends Anal. Chem,2006

3. A rationale for determining testing, and controlling specific impurities in pharmaceuticals that posses potential for genotoxicity;Muller;Reg. Toxicol. Pharmacol.,2006

4. Guideline on the limits of genotoxic impurities, EMA guidance EMEA/CHMP/QWP/251344/2006.

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

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