Overcome N-Nitrosamine Analysis Challenges with Chromatographic and Mass Spectrometry Techniques

Register free: https://www.biopharminternational.com/bp_w/overcome​

Event Overview:

N-nitrosamine analysis has been a hot topic in the pharmaceutical industry since 2018 when the suspected carcinogens were found in several angiotensin II receptor blockers, commonly known as sartans. Subsequently, the contaminants have been found in batches other sartans, ranitidine, and in some slow-release metformin formulations leading to the recall with of products within the European and US markets. In response, more stringent manufacturing requirements have been employed for these products and the industry has taken steps to evaluate the root cause of the N-nitrosamine contamination and subsequent risk assessment and control.

This webcast will examine the challenges in developing an analytical method that is able to meet the increasingly stringent regulatory requirements for these contaminants. Discussion topics include chromatography, limits of quantification, and selectivity in challenging matrices.

Key Learning Objectives:

• Review the basics for the analysis of N-nitrosamines
• Learn orthogonal mass spectrometry techniques and how they can be employed
• Learn to overcome the chromatographic challenges presented by APIs and drug products

Speaker: Rolf Kern, Technical Marketing Manager – Pharma, SCIEX

Time and Date: Monday, Oct.19, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing until Oct. 19, 2021

Sponsor: SCIEX

Register free: https://www.biopharminternational.com/bp_w/overcome​