Potentially Mutagenic Impurities (PMIs): Optimizing Toxicological and Analytical Assessments-Reference-Cited by-同舟云学术

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Potentially Mutagenic Impurities (PMIs): Optimizing Toxicological and Analytical Assessments

Published:2014-07-01 Issue:7 Volume:18 Page:836-839
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Snodin David¹

Affiliation:

1. Xiphora Biopharma Consulting, Bristol, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op5001594

Reference28 articles.

1. ICH M7 (step 3):http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/02/WC500139217.pdf.

2. Carbadox. FDA Review:http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm064222.htm.

3. EPA AEGL on chloroformates:http://www.epa.gov/oppt/aegl/pubs/chloroformates_interim.pdf.

4. Trobalt. EPAR:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001245/WC500104839.pdf.

Cited by 3 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. Demonstrating laboratory proficiency in bacterial mutagenicity assays for regulatory submission;Mutation Research/Genetic Toxicology and Environmental Mutagenesis;2019-12

2. Analytical control strategies for mutagenic impurities: Current challenges and future opportunities?;TrAC Trends in Analytical Chemistry;2018-04

3. Applications of TiCl3 as a Diagnostic Reagent for the Detection of Nitro- and N-Oxide-Containing Compounds as Potentially Mutagenic Impurities Using Ultrahigh-Performance Liquid Chromatography Coupled with High-Resolution Mass Spectrometry;Organic Process Research & Development;2015-12-18

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