Development of validated stability-indicating assay methods--critical review

J Pharm Biomed Anal. 2002 Jun 15;28(6):1011-40. doi: 10.1016/s0731-7085(02)00047-x.


This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is discussed. Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of SIAMs for combination products, etc. are also addressed. The applicability of pharmacopoeial methods for the analysis of stability samples is discussed. The requirements of SIAMs for stability study of biotechnological substances and products are also touched upon.

Publication types

  • Review

MeSH terms

  • Chemistry, Pharmaceutical / methods*
  • Chromatography, High Pressure Liquid
  • Computer Simulation
  • Drug Contamination*
  • Drug Stability*
  • Pharmaceutical Preparations / analysis*
  • Reproducibility of Results
  • Technology, Pharmaceutical / standards*


  • Pharmaceutical Preparations