Nitrosamine Impurity Analysis Webinar

Solvias is pleased to announce its upcoming webinar ‘Nitrosamine Impurity Analysis’.

Dr Karl Abele will describe Solvias approach to N-Nitrosamine analysis focusing on two approaches:

1. Generic quantification of six volatile N-nitrosamines (NDMA, NDEA, EIPNA, DPNA, DIPNA, NDBA between 20-100 ppb) within chemically manufactured API’s and DP’s with an LOD of 10 ppb.
a. Proprietary chemistry, minimising interference from API’s and DP’s
b. No chromatographic optimisation required
c. Verification by spiked samples

2. Use of HRAM-LC/MS equipment for trace analysis with Q-Standard GMP
a. Volatiles and non-volatile N-nitrosamines
b. Product-specific validations required
c. Product-specific LOQ’s (ppb range)

Dr Mark Yang will describe the development of an analytical method for a range of nitrosamines and how Thermo Scientific™ Orbitrap Exploris™ 120 High Resolution, Accurate Mass (HRAM) mass spectrometer provides reliable and comprehensive information on nitrosamines impurities that may be present in pharmaceutical products, controlled by powerful and compliant-ready Thermo Scientific™ Chromeleon™ CDS software.

Take-away messages:
• A range of strategies for nitrosamine analysis
• Overview of current regulatory landscape for genotoxic impurities
• Utilisation of high-resolution accurate mass (HRAM) mass spectrometry systems for increased confidence in data
• A comparison of different approaches to the problem


Dr Karl Abele
Team Leader Extractables & Leachables, Solvias

Dr Hao (Mark) Yang
Sr. Product Application Scientist, Thermo Fisher Scientific

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