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_____ Brought to you by Thermo Fisher Scientific _____

Comprehensive solutions to Nitrosamine impurity analysis: an industry case study

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  December 16, 2020

  8:00 a.m. PST, 11:00 a.m. EST, 16:00 GMT, 17:00 CET

 

Overview

 

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, minimizing interference from API's and DP's
b. No chromatographic optimization 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)

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.

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Key Learning Objectives

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

Speakers

Dr. Karl Abele
Team Leader Extractables & Leachables,
Solvias
Hao (Mark) Yang
Sr. Product Application Scientist,
Thermo Fisher Scientific
 

Moderator

Melissa O'Meara
Forensic Science Consultant
C&EN Media Group
 

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