STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

  • Megha Pokharana B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India
  • Rajat Vaishnav B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India
  • Anju Goyal B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India
  • Aseem Shrivastava B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

Abstract

Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Stability studies are required to be conducted in a planned way following the guidelines issued by ICH, who and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been included in the present review

Keywords: stability testing, stability studies, stability, pharmaceutical products, international council for harmonisation

 

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Author Biographies

Megha Pokharana, B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

Rajat Vaishnav, B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

Anju Goyal, B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

Aseem Shrivastava, B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

B.N. Institute of Pharmaceutical Sciences, Udaipur (Raj.) 313001, India

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Pokharana M, Vaishnav R, Goyal A, Shrivastava A. STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS. JDDT [Internet]. 15Mar.2018 [cited 30Oct.2020];8(2):169-75. Available from: http://www.jddtonline.info/index.php/jddt/article/view/1564