Recent advances in trace analysis of pharmaceutical genotoxic impurities
- 13 November 2009
- journal article
- review article
- Published by Elsevier BV in Journal of Pharmaceutical and Biomedical Analysis
- Vol. 51 (5), 999-1014
- https://doi.org/10.1016/j.jpba.2009.11.009
Abstract
No abstract availableKeywords
This publication has 79 references indexed in Scilit:
- 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
- Genotoxic Impurities: A Quantitative ApproachJournal of Liquid Chromatography & Related Technologies, 2008
- Regulating impurities in pharmaceutical products: a tolerability of risk approach?Expert Review of Clinical Pharmacology, 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
- Toxicological overview of impurities in pharmaceutical products☆Advanced Drug Delivery Reviews, 2007
- Determination of genotoxic phenylhydrazine agaritine in mushrooms using liquid chromatography–electrospray ionization tandem mass spectrometryFood Additives & Contaminants, 2006
- Regulation of genotoxic and carcinogenic impurities in drug substances and productsTrAC Trends in Analytical Chemistry, 2006
- A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicityRegulatory Toxicology and Pharmacology, 2006
- Carcinogenicity categorization of chemicals—new aspects to be considered in a European perspectiveToxicology Letters, 2004
- Acceptability of Low Levels of Genotoxic Impurities in New Drug SubstancesInternational Journal of Pharmaceutical Medicine, 2004