• Anjali Gusain

The stability studies are one of the very important parameters of pharmaceutical products. 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. Stability assessment and shelf-life prediction is usually a major focus of a pharmaceutical scientist’s attention in the development of all dosage forms. It is important in the development of small molecule drug products as well, particularly given the importance of the physical state of the drug in determining stability characteristics. The stability of the pharmaceutical formulation during its entire shelf life in its final packaging is an important matter. Stability study does not only cover the physiochemical aspects of the drug but also explains the safety and efficacy of the product during its entire shelf life. 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. . Stability 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 a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labelling instructions. Current trends in stability testing also described.

Stability, Stability studies, Shelf Life, Pharmaceutical drug products; Dosage forms and ICH guidelines.

"RECENT TRENDS OF STABILITY STUDY OF PHARMACEUTICAL DOSAGE FORMS AND ITS SELF LIFE – A REVIEW ARTICLE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 3, page no.554-572, March-2019, Available :http://www.jetir.org/papers/JETIR1903188.pdf

"RECENT TRENDS OF STABILITY STUDY OF PHARMACEUTICAL DOSAGE FORMS AND ITS SELF LIFE – A REVIEW ARTICLE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 3, page no. pp554-572, March-2019, Available at : http://www.jetir.org/papers/JETIR1903188.pdf