As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.
At Aragen, our Analytical team follows a rigorous three-step approach-Risk Assessment, Confirmatory Testing, and Remediation Planning—to ensure that pharmaceutical products are safe for human use. By utilizing advanced methodologies and thorough testing, we adhere to global quality standards, safeguarding public health.
New Marketing Authorization and Batch Release: Comprehensive evaluation and testing of each batch to ensure compliance with regulatory standards prior to being marketed.
Stability Storage & Testing: Long-term stability studies to track the presence of NSAs and nitrosamine drug substance related impurities (NDSRI) over time.
Query or Deficiency Handling: Rapid development and validation services to address urgent queries or deficiencies.
Cleaning Validation: Ensuring cleaning processes meet safety standards by testing for nitrosamine residues.
