Addressing The Evolving Challenge of Analyzing N-Nitrosamines in Pharmaceuticals

Brought to you by Sannova Analytical Inc.

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 Objectivesï¼š

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 regulatorâ€™s and clientâ€™s needs in this matter.

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