Addressing the challenge of nitrosamine contamination demands a precisely customised approach to risk assessment, analytical testing, and mitigation. A one-size-fits-all solution simply is not effective.
The complexity stems from two key factors:
- The required scope of testing varies significantly based on your specific products particularly for NDSRI’s.
- Analytical methodology often requires adaptation or bespoke development for individual matrices. This is essential to ensure suitable analyte recovery and to eliminate interferences that could lead to false-positives.
LCMS/MS remains the gold standard for the majority of nitrosamine analysis, and it is the core technology deployed in our laboratory.
Comprehensive analytical capability
Effective mitigation of nitrosamine risk demands a broad spectrum of analytical capability, extending beyond finished product testing. We are equipped to test for precursors in excipients, solvents, or as manufacturing residues in the API.
Our 25 years of history in pharmaceutical testing has built this extensive suite of capabilities, ensuring we can comprehensively address your nitrosamine concerns.
Real-time support and regulatory responsiveness
All analytical testing and method development are conducted at our laboratory in Sydney, Australia. For the highly bespoke solutions required in nitrosamine analysis, this local presence is critical. It allows for real-time discussion and rapid iteration on analytical developments, providing the responsiveness you need to confidently meet your regulatory obligations.