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Updated: Mar 12, 2026

NMR-Based Fragment Screening in a Minimum Sample but Maximum Automation Mode
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Minimizing in Source Fragmentation for Mass Spectrometry Based NDSRI Analytical Procedures: A Case Study of

Jinhui Zhang1, Mack Shih2, Jingyue Yang2

  • 1Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. Jinhui.Zhang@fda.hhs.gov.

The AAPS Journal
|March 11, 2026
PubMed
Summary

In-source fragmentation (ISF) in liquid chromatography-mass spectrometry (LC-MS) can impact nitrosamine drug substance-related impurity (NDSRI) measurements. This study shows how to minimize ISF during analytical method development for accurate NDSRI quantitation.

Keywords:
NDSRI (Nitrosamine drug substance-related impurity)analytical procedure developmentin source fragmentationmass spectrometryprior knowledgerisk assessment

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