Liquid Chromatography–Mass Spectrometry Method for Determination of N‐Methyl‐N‐Nitrosopyridin‐4‐Amine in a Vonoprazan Fumarate Drug

R Chilukuri, K Sayyad, LP Kowtharapu… - Separation …, 2024 - Wiley Online Library
ABSTRACT N‐methyl‐N‐nitrosopyridin‐4‐amine (4‐MNPA) was one of the nitrosamine
impurities observed in the vonoprazan fumarate (VF) during the production of the VF‐active …

Gas chromatography mass spectrometer determination of dimethylamine impurity in N,N‐dimethylformamide solvent by derivatization of N,N‐dimethylbenzamide …

S Kousrali, LP Kowtharapu… - Biomedical …, 2024 - Wiley Online Library
This study describes the development of a reliable and linear analytical method for precisely
determining dimethylamine impurity in N, N‐dimethylformamide solvent utilizing a benzoyl …

Headspace Gas Chromatography–Mass Spectrometry Method for Determination of Class-I Residual Solvents in Several Drug Substances: Method Evaluation by …

K Sayyad, LP Kowtharapu… - Journal of AOAC …, 2024 - academic.oup.com
Background Class-I residual solvents such as 1, 1-dichloroethene, 1, 1, 1-trichloroethane,
carbon tetrachloride, benzene, 1, 2-dichloroethane are toxic, environmental hazards, and …