Comprehensive solutions to Nitrosamine impurity analysis:

an industry case study

DATE

December 16, 2020

TIME

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.

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

Brought to you by:

Speakers

Dr. Karl Abele
Team Leader Extractables & Leachables,
Solvias

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

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

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