Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives
- 17 June 2015
- journal article
- review article
- Published by American Chemical Society (ACS) in Organic Process Research & Development
- Vol. 19 (11), 1486-1494
- https://doi.org/10.1021/acs.oprd.5b00128
Abstract
No abstract availableKeywords
This publication has 42 references indexed in Scilit:
- Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impuritiesRegulatory Toxicology and Pharmacology, 2013
- Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspectiveJournal of Pharmaceutical and Biomedical Analysis, 2011
- Low level determinations of methyl methanesulfonate and ethyl methanesulfonate impurities in Lopinavir and Ritonavir Active pharmaceutical ingredients by LC/MS/MS using electrospray ionizationJournal of Pharmaceutical and Biomedical Analysis, 2011
- Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbalsJournal of Pharmaceutical and Biomedical Analysis, 2010
- Recent advances in trace analysis of pharmaceutical genotoxic impuritiesJournal of Pharmaceutical and Biomedical Analysis, 2009
- Development and validation of an automated static headspace gas chromatography–mass spectrometry (SHS-GC–MS) method for monitoring the formation of ethyl methane sulfonate from ethanol and methane sulfonic acidJournal of Pharmaceutical and Biomedical Analysis, 2008
- Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs)Journal of Pharmaceutical and Biomedical Analysis, 2008
- A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substancesJournal of Pharmaceutical and Biomedical Analysis, 2008
- Control and analysis of alkyl esters of alkyl and aryl sulfonic acids in novel active pharmaceutical ingredients (APIs)Journal of Pharmaceutical and Biomedical Analysis, 2008
- A generic approach for the determination of residues of alkylating agents in active pharmaceutical ingredients by in situ derivatization–headspace–gas chromatography–mass spectrometryJournal of Pharmaceutical and Biomedical Analysis, 2007