STABILITY STUDY: REGULATORY REQUIREMENT

Authors

  • Rina H. Gokani Department of Quality Assurance, S. J. Thakkar, Rajkot, Gujarat
  • Kinjal N. Desai Department of Quality Assurance, S. J. Thakkar, Rajkot, Gujarat

DOI:

https://doi.org/10.7439/ijapa.v2i4.42

Keywords:

Phytochemical study, Mikania scandens, Asteraceae, Antiulcer activity, Lansoprazol

Abstract

Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions.

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Published

2012-12-31

Issue

Vol. 2 No. 4 (2012): Oct - Dec

Section

Review Article

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How to Cite

1.
STABILITY STUDY: REGULATORY REQUIREMENT. Int J of Adv in Phar Ana [Internet]. 2012 Dec. 31 [cited 2026 Jan. 3];2(4):73-8. Available from: https://ssjournals.co.in/index.php/ijapa/article/view/1359
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