Symbiotic Research: Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-Metformin
Symbiotic Research on Utilization of 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-Metformin
International Trade Center, Mount Olive, New Jersey--SYMBIOTIC RESEARCH, LLC (SRL), a Tentamus Company, announces a multi-residue screening and quantitative UPLC-APCI-HRMS method developed for several targeted Nitrosamine impurities as chemical cross-contaminants in manufactured drug product Metformin. The HRMS component utilizes Time of Flight (TOF) mass spectrometry. The U.S. FDA recommends drug manufacturers to monitor specific drugs which are prone to contain nitrosamines as impurities. Nitrosamines in these drugs must be monitored and quantified by HRMS techniques, as opposed to conventional nominal mass LC-MS/MS systems. The US-FDA has already released its own high resolution full scan LC-MS quantitative method for screening such impurities: www.fda.gov/media/138617/download.
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)
Figure 1. The UHPLC INFINITY II interfaced to AB SCIEX X500B was the instrument utilized to develop the Nitrosamine impurity method in Metformin DP
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.