Ensure Your Products’ Safety with Expert Nitrosamine Analysis

Information sheet

At Cambrex, we understand the critical importance of ensuring the safety and integrity of your pharmaceutical products. Nitrosamines, a class of potent carcinogenic impurities, pose significant risks if present in drug substances and products. Our comprehensive analytical services are designed to help you detect, quantify and control nitrosamine impurities, ensuring compliance with regulatory standards and safeguarding patient health.

Our capabilities include:

  • Initial Risk Assessment for potential nitrosamine formation in your chemical processes.
  • Chemical process development and synthesis of custom nitrosamines.
  • Qualification of nitrosamine reference standards.
  • Product-specific method development and validation.
  • Comprehensive cGMP testing.
  • Expedited service options available by request.

Equip yourself with the knowledge you need to protect your products. Our detailed information sheet provides insights into our analytical capabilities, common nitrosamines we analyze, and how we can help ensure the safety of your drug substances and products.