Pine Lake laboratories can perform the nitrosamine impurities analyses following the FDA published methods for Losartan, Valsartan, Metformin, Ranitidine, Rifampin, Rifapentine and Varenicline.   For additional drugs, we can perform the risk assessment, nitrosamine analysis and toxicological risk assessment for the specific drug product.   Our materials expert will identify all of the potential sources of nitrosamines.   Once the targeted nitrosamines have been identified, our GMP analytical team can develop and validate sensitive GC-MS and LC-MS/MS methods for nitrosamines in any API or drug products.   Finally, we can support the final results with a toxicological risk assessment when needed.

‍