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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.
Bercu JP, Galloway SM, 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 EA, Custer L, Jolly RA, Thybaud V. Bercu JP, et al. Regul Toxicol Pharmacol. 2018 Apr;94:172-182. doi: 10.1016/j.yrtph.2018.02.001. Epub 2018 Feb 9. Regul Toxicol Pharmacol. 2018. PMID: 29408293
Potentially mutagenic impurities: analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities.
Galloway SM, Vijayaraj Reddy M, McGettigan K, Gealy R, Bercu J. Galloway SM, et al. Regul Toxicol Pharmacol. 2013 Aug;66(3):326-35. doi: 10.1016/j.yrtph.2013.05.005. Epub 2013 May 17. Regul Toxicol Pharmacol. 2013. PMID: 23688841
47 results