All the services you expect from a Analytical Service laboratory
Nitrosamines are a class of compounds with a chemical structure of a nitroso group bonded to an Amine. Nitrosamine compounds are known genotoxic substances, and some are even classified as probable or possible human carcinogens. To assure the safety of drug products, we can analyse the drug products with fast turnaround times and the most effective test methods. We can quickly and efficiently identify any issues with the knowledge of impurities and experience in trace level analysis.
We have the experience of developing the test methods with GCMSMS and LCMSMS, to detect the presence of nitrosamine traces in drug products, raw materials, and active pharmaceutical ingredients (APIs), at recommended LOD/LOQ levels and specifications.
In current scenario regulatory agencies are recommending that all manufacturers and providers test their products to protect patients and ensure that effective measures are taken to prevent these impurities from being present in medicines.
Services include:
- Analytical method development and validation of specific impurities
- Batch analysis as per the customer requirements