Revin Labs Private Limited

Testing Services

Testing Services

Revin offers a wide range of testing services for the purpose of regulatory submissions at leading national and international regulatory authorities. Studies are conducted based on GLP, ICH, USP, IP, BP, EP, JP, ISO guidelines. State of the art services coupled with a highly experienced scientific team. We deliver quality reports world wide. 

We do all type of analysis as per Pharmacopoeia or Customer Testing Procedure.

Nitroamines and GTIs impurities study at Revin Labs

Revin measures the unknowns and quantification of impurities (GTI's and Nitrosamines) in the pharmaceuticals and other related compounds by using LCMSMS and GCHSMS/GCMS. We have both advanced LC and GC mass spectrometries to test GTI's and Nitrosamine impurities in the finished products as well as intermediates. In 2018, the FDA began investigating NDMA and other nitrosamine impurities, such as NDEA, NMBA, NMPA, NIPEA and NDIPA, which are also classified as probable human carcinogens and that were detected in some blood-pressure and heart-failure medicines. Revin has developed a test method, based on LC-MSMS and GCHSMS/GCMS to detect the presence of nitrosamine and GTI traces in drug products, raw materials and active pharmaceutical ingredients (APIs) as per regulatory agencies specifications.