Overview
This whitepaper discusses the challenges of analyzing pharmaceuticals for trace levels of nitrosamines, both known and unknown. Adding to the challenge is the fact that U.S. and European regulators have taken different approaches to regulating nitrosamine contamination.
Key Objectives:
- What are nitrosamines/chemical understanding
- Method of analysis (by GC-MS, LC-MS, and most recently HRMS)
- Nitrosamines in drug products, APIs, excipients etc. is an evolving research area
- Sannova, with high-end instrumentation and expertise, has the capability to nimbly adapt to both regulator’s and client’s needs in this matter.