Stability Testing of Pharmaceutical Products
来源:
|
作者:pmo90dc87
|
发布时间 :2018-08-16
|
2940 次浏览:
|
分享到:
ABSTRACT
Stability studies 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. These 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 presented in a concise manner in the present review
INTRODUCTION
Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation. Scientific and commercial success of a pharmaceutical product can only be ensured with the understanding of the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan. The most important steps during the developmental stages include pharmaceutical analysis and stability studies that are required to determine and assure the identity, potency and purity of ingredients, as well as those of the formulated products (Singh et al., 2000). 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 (Kommanaboyina et al., 1999). In other words, it is the extent to which a product retains, within the specified limits, throughout its period of storage and use, the same properties and characteristics possessed at the time of its packaging. Stability testing thus evaluates the effect of environmental factors on the quality of the a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions. Moreover, the data generated during the stability testing is an important requirement for regulatory approval of any drug or formulation (Singh et al., 2000).
简体中文
English
