Witryna23 wrz 2024 · Background Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor drug for treating premature ejaculation. This study was designed to develop and validate a sensitive and selective LC–MS/MS method for trace analysis of genotoxic impurity ethyl methanesulfonate in Dapoxetine hydrochloride. Results … Witryna15 kwi 2024 · Tandem mass spectrometry and specifically multiple reaction monitoring (MRM) is an alternate approach to enhance the likelihood of impurity differentiation, provided unique fragment ions are formed in detectable amounts for each impurity.
Improving LC-MS Analysis of Basic Impurities Using CORTECS C
WitrynaResults: The Fexofenadine API impurity profile was quickly obtained. ™ Introduction Pharmaceutical impurity analysis is crucial for drug R&D, production, and post-marketing surveillance. LCMS is routinely used for impurity analysis because of its speed and sensitivity. For rapid, accurate, and confident impurity ID, very high Witrynaof eight nitrosamine impurities in metformin drug substance. Metformin is an antihyperglycemic agent of the biguanide class, used for the management of type II diabetes. This application note describes a highly selective and sensitive LC/MS/MS method using the Agilent 6470 triple quadrupole LC/MS for the detection and city and county credit union in minneapolis
Validating performance of an Agilent ICP-MS for USP …
Witryna21 kwi 2024 · Nitrosamine impurities can stem from certain chemicals in raw materials, reaction conditions during the manufacturing process or from the active pharmaceutical ingredient (API) itself. This means, rather than testing random batches, the entire manufacturing process will require nitrosamine testing. WitrynaThe unexpected finding of nitrosamine impurities in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence. Witrynathe analysis of organic impurities are chromatographic methods coupled with mass spectrometry (GC-MS, LC-MS). They allow direct analysis of even trace amount of … city and county credit union minnetonka