Symbiotic Research: Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-Metformin
Ultra Performance Liquid Chromatography-Atmospheric Pressure Chemical Ionization-High Resolution Mass Spectrometry (UPLC-APCI-HRMS) Method for Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-MetforminMount Olive, )
Dan Safarpour, Ph.D., CEO of SRL presented this research at the 2022 Latin-American Symposium on Biotechnology, Biomedical, Biopharmaceutical and Industrial Applications of Capillary Electrophoresis and Microchip Technology (LACE Symposium), December 3-7, 2022, Pacifica Salud Hospital, Panama City, Panama. Dr. Safarpour stated “The Nitrosamine impurities studied at our Symbiotic Research Lab currently are limited to NDMA, NDIPA, NEIPA, & NDBA. Other impurities such as NDEA, NMPA, NMBA are under investigation and method development. Using UPLC-APCI-HRMS with TOF, a 5 ng/mL detection level is easily achievable, with ample signal to noise (S/N), while maintaining over 22,000 mass resolution.” (See Chromatograms below).
About Symbiotic Research
SRL (a Tentamus company) is a full GLP, C-14 licensed, life sciences contract research organization which provides in-life and analytical research services to its global clients. SRL is located at 350 Clark Drive, Mount Olive, NJ 07828.