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Regulatory Guidelines on Stability Testing and Trending of Requirements

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Methods for Stability Testing of Pharmaceuticals

Part of the book series: Methods in Pharmacology and Toxicology ((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.

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Authors and Affiliations

  1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

    Dilip Kumar Singh & Saranjit Singh

  2. Select Biosciences India Private Limited, Chandigarh, India

    Sanjay Bajaj

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  1. Dilip Kumar Singh
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  2. Saranjit Singh
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  3. Sanjay Bajaj
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  1. Select Biosciences India Private Limited, Chandigarh, India

    Sanjay Bajaj

  2. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

    Saranjit Singh

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Singh, D.K., Singh, S., Bajaj, S. (2018). Regulatory Guidelines on Stability Testing and Trending of Requirements. In: Bajaj, S., Singh, S. (eds) Methods for Stability Testing of Pharmaceuticals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7686-7_1

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