Headspace Gas Chromatography Mass Spectrometry Method for Determination of class-I Residual Solvents in Several Drug Substances: Method Evaluation by Quality by Design Statistical Tool.
Kousrali SayyadLeela Prasad KowtharapuTanmoy MondalPublished in: Journal of AOAC International (2024)
No research studies are reported for the determination of class-I residual solvents in lincomycin hydrochloride, dapagliflozin, vonoprazan fumarate, telmisartan drug substances. The proposed study is to develop the common method for quantification of class-I residual solvents for drug substances. QbD concept is utilized in the method performance verification.