Trace level liquid chromatography tandem mass spectrometry quantification of the mutagenic impurity 2-hydroxypyridine N-oxide as its dansyl derivative

Author:

Ding Wei,Huang Yande,Miller Scott A.,Bolgar Mark S.

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference25 articles.

1. EMEA-CHMP, Guideline on the Limit of Genotoxic Impurities CPMP/SWP/5199/02, EMEA/CHMP/QMP/251344/2006, 28 June, http://www.ema.europa.eu.

2. A retionale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity;Müller;Regul. Toxicol. Pharm.,2006

3. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test;Ames;Mutat. Res.,1975

4. Revised methods for the Salmonella mutagenicity test;Maron;Mutat. Res.,1983

5. Mutagen testing using TRP+ reversion in Escherichia coli;Green;Mutat. Res.,1976

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