Symbiotic Research: Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-Metformin
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.
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.
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
CEO Symbiotic Research
Telefon: +1 (908) 887 4345
E-Mail: dan.safarpour@symbioticresearch.net
