Comprehensive solutions to Nitrosamine impurity analysis: an industry case study

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.

• Proprietary chemistry, minimizing interference from API’s and DP’s
• No chromatographic optimization required
• Verification by spiked samples

2. Use of HRAM-LC/MS equipment for trace analysis with Q-Standard GMP

• Volatiles and non-volatile N-nitrosamines
• Product specific validations required
• Product specific LOQ’s (ppb range)

Thermo Fisher Scientific content:

Dr. Mark Yang will describe the development of a 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.

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

Who Should Attend:

• Analytical scientsts in pharma, CDMO or CMO labs
• Researchers/ R&D Managers
• Laboratory Managers/ Directors / Supervisors
• Laboratory Technicians / Operators

Presenter: Dr. Karl Abele (Team Leader Extractables & Leachables, Solvias)

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

Presenter: Melissa O'Meara (Forensic Science Consultant, C&EN Media Group)