Matrix deactivation: A general approach to improve stability of unstable and reactive pharmaceutical genotoxic impurities for trace analysis-Reference-Cited by-同舟云学术

Matrix deactivation: A general approach to improve stability of unstable and reactive pharmaceutical genotoxic impurities for trace analysis

Published:2010-05 Issue:1 Volume:52 Page:30-36
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Sun Mingjiang,Bai Lin,Terfloth Gerald J.,Liu David Q.,Kord Alireza S.

Publisher

Elsevier BV

Subject

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

Reference26 articles.

1. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process;Liu;J. Pharm. Biomed. Anal.,2009

2. EMEA–CHMP, Guideline on the Limit of Genotoxic Impurities CPMP/SWP/5199/02, EMEA/CHMP/QMP/251344/2006, 28 June 2006.

3. US FDA, Guidance for industry: genotoxic and carcinogenic impurities in drug substances and products: recommended approaches (draft), December 2008, http://www.fda.gov/cder/guidance.

4. EMEA Q&A, EMEA/CHMP/SWP/431994/2007, http://www.emea.europa.eu/pdfs/human/swp/43199407en.pdf.

5. An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals;Delaney;Regul. Toxicol. Pharmacol.,2007

Cited by 26 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A Simple and Sensitive UPLC–MS/MS Method for the Simultaneous and Trace Level Quantification of Two Potential Genotoxic Impurities in Midazolam Drug Substance;Chromatographia;2022-11-23

2. Strategic Approaches to the Chromatographic Analysis of Mutagenic Impurities;Mutagenic Impurities;2021-12-08

3. Low-Level Quantification of tert-Butyl Nitrite in a Pharmaceutical Intermediate;Organic Process Research & Development;2021-10-16

4. Gas chromatography/mass spectrometry analysis of organic acid profiles in human serum: A protocol of direct ultrasound‐assisted derivatization;Rapid Communications in Mass Spectrometry;2021-07-07

5. Development and Validation of a Sensitive GC–MS/MS Method for the Determination of Five Potential Genotoxic Impurities in Abiraterone Acetate;Journal of Chromatographic Science;2021-05-31