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Regulatory Guidelines on Stability Testing and Trending of Requirements

  • Dilip Kumar Singh
  • Saranjit Singh
  • Sanjay Bajaj
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

Stability of drug substances and their products is required to be ensured throughout their retest period/shelf-life. Various guidelines explaining the concept, procedures, and protocols have been developed and issued by international, regional, and national regulatory agencies to help the manufacturers in the generation of valid and acceptable stability data. This chapter enlists and briefly discusses the available stability guidelines, and also outlines the trends of emerging requirements.

Key words

Regulatory guidelines Stability testing Stability guidelines ICH guidelines WHO guidelines USFDA guidelines 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Dilip Kumar Singh
    • 1
  • Saranjit Singh
    • 1
  • Sanjay Bajaj
    • 2
  1. 1.Department of Pharmaceutical AnalysisNational Institute of Pharmaceutical Education and Research (NIPER)MohaliIndia
  2. 2.Select Biosciences India Private LimitedChandigarhIndia

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