LC–MS-DRIVEN METABOLITE CHARACTERIZATION IN DRUG DEVELOPMENT: REGULATORY PERSPECTIVES AND METHOD VALIDATION

Authors

  • KAJAL PAL ,Dr. Nalini Kanta Sahoo Author

DOI:

https://doi.org/10.48047/

Keywords:

Metabolite identification; LC–MS/MS; FDA regulatory framework; MIST guidance; ICH M10; Bioanalytical method validation; Drug metabolism

Abstract

Metabolite identification and characterization represents a cornerstone of modern pharmaceutical development, with liquid chromatography-mass spectrometry (LC/MS) emerging as the analytical technique of choice for  regulatory compliance. This research paper examines 

Downloads

Download data is not yet available.

Downloads

Published

2026-05-26

Issue

Vol. 17 No. 5 (2026): Volume 17 Issue 5 (2026)

Section

Articles