Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides-Reference-Cited by-同舟云学术

Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

Published:2018-04 Issue: Volume:94 Page:172-182
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Bercu J.P.,Galloway S.M.,Parris P.,Teasdale A.,Masuda-Herrera M.,Dobo K.,Heard P.,Kenyon M.,Nicolette J.,Vock E.,Ku W.,Harvey J.,White A.,Glowienke S.,Martin E.A.,Custer L.,Jolly R.A.,Thybaud V.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference103 articles.

1. Vinyl acetate monomer (VAM) genotoxicity profile: relevance for carcinogenicity;Albertini;Crit. Rev. Toxicol.,2013

2. Toxicological assessment of 2-methyltetrahydrofuran and cyclopentyl methyl ether in support of their use in pharmaceutical chemical process development;Antonucci;Org. Process Res. Dev.,2011

3. Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP;Ashby;Mutat. Res.,1988

4. Toxicological Profile for Formaldehyde;Agency for Toxic Substances and Disease Registry (ATSDR),1999

5. Carcinogenicity of halothane in Swiss/ICR mice;Baden;Anesthesiology,1979

Cited by 44 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. Safety Assessment of Protein A and Derivation of a Parenteral Health-Based Exposure Limit;Regulatory Toxicology and Pharmacology;2024-09

2. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices;Chemical Research in Toxicology;2024-08-19

3. Retrospective application of ICH M7 to anti-hypertensive drugs in Brazil: Risk assessment of potentially mutagenic impurities;Regulatory Toxicology and Pharmacology;2024-08

4. Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach;Regulatory Toxicology and Pharmacology;2024-06

5. Analysis of non-mutagenic substances in the context of drug impurity assessment – Few are potent toxicants;Regulatory Toxicology and Pharmacology;2024-06