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Comprehensive solutions to new requirements for nitrosamine impurity analysis

An on-demand webinar is now available with Dr. Karl Abele describing the Solvias approach to N‑nitrosamine analysis focusing on two approaches.

The generic quantification of six volatile N-nitrosamines (NDMA, NDEA, EIPNA, DPNA, DIPNA, NDBA between 20-100 ppb) within chemically manufactured APIs and DPs with an LOD of 10 ppb.

  • The generic quantification of six volatile N-nitrosamines (NDMA, NDEA, EIPNA, DPNA, DIPNA, NDBA between 20-100 ppb) within chemically manufactured APIs and DPs with an LOD of 10 ppb
  • And the use of HRAM-LC/MS equipment for trace analysis with Q-Standard GMP, volatiles and non-volatile N-nitrosamines

 

NITROSAMINES On-demand webinar

 

Participants will learn:

A range of strategies for nitrosamine analysis

Overview of current regulatory landscape for genotoxic impurities

Utilization of high-resolution accurate mass (HRAM) mass spectrometry systems for increased confidence in data

A comparison of different approaches to the problem

In addition, Dr. Hao Yang, Thermo Fisher Scientific, describes the development of an analytical method for a range of nitrosamines and how the Thermo Scientific Orbitrap Exploris 120 mass spectrometer provides reliable and comprehensive information on nitrosamines impurities that may be present in pharmaceutical products, all under compliance-ready control with Thermo Scientific Chromeleon Chromatography Data System.


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