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Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: Safety considerations of impurities in pharmaceutical products and surveying the impurity landscape.
Alsante KM, Huynh-Ba KC, Baertschi SW, Reed RA, Landis MS, Furness S, Olsen B, Mowery M, Russo K, Iser R, Stephenson GA, Jansen P. Alsante KM, et al. AAPS PharmSciTech. 2014 Feb;15(1):237-51. doi: 10.1208/s12249-013-0061-z. Epub 2013 Dec 21. AAPS PharmSciTech. 2014. PMID: 24363207 Free PMC article. No abstract available.
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products.
Zheng J, Kirkpatrick CL, Lee D, Han X, Martinez AI, Gallagher K, Evans RK, Mudur SV, Liang X, Drake J, Buhler LA, Mowery MD. Zheng J, et al. Among authors: mowery md. AAPS J. 2022 Jan 6;24(1):23. doi: 10.1208/s12248-021-00669-8. AAPS J. 2022. PMID: 34993666 Free PMC article.
12 results