Agrama is the only private laboratory that has the necessary technology to analyze ndma in ranitidine as established by the fda
In Agrama we are controlling the level of NDMA in drugs, working for important companies in the pharmaceutical sector. We are the only laboratory in Spain that follows the method used by the FDA (Method for the Determination of NDMA in Ranitidine Drug Substance and Drug Product FY19-177-DPA-S) for the analysis of NDMA in ranitidine samples. Agram based on this method, using LC-HRMS-Orbitrap has validated methods for the analysis of NDMA in other drugs. Dimethylnitrosamine (NDMA) is a known environmental pollutant and is found in water and food. NDMA is classified as a probable human carcinogen according to the results of laboratory tests. The FDA has found that some medications contain an impurity of NDMA at low levels. Although NDMA can cause harm if taken in large quantities, the levels that the FDA is finding in the ranitidine drug in preliminary tests barely exceed the amounts that can be expected to be found in common foods.