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/....
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.
www.SymbioticResearch.com
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Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 90 locations worldwide. More than 4,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
