STABILITY TESTING OF NEW PHARMACEUTICAL DRUG PRODUCTS

The ability of a specific pharmaceutical substance or product in a specific closed system (container), to remain stable or among its specifications of physical, therapeutic, chemical, microbiological parameters right through its shelf life, it is known as the stability. The stability studies is a vital parameter in every field including the pharmaceutical sciences for the manufacturing of new pharmaceutical drugs as well as new pharmaceutical formulations. The assumption of the shelf-life is vital for the manufacturing of a pharmaceutical product of all the dosage forms and also the stability testing is performed to determine the instructions and conditions for the label and storage of a specific pharmaceutical dosage form.

For the manufacturing and acceptance of the pharmaceutical product i.e. the drug product or the API (Active Pharmaceutical Ingredient) i.e. the drug substance, stability testing are needed. For the acceptance and approval of pharmaceutical finished products, stability testing are necessary for confirming the products safety, quality and efficacy right through its shelf life.

This review paper represents the stability parameter which is used for the analysis of new finished product. The stability testing are required to be performed in a planned manner as per the ICH (International Conference on Harmonisation), WHO (World Health Organization) or other regulatory bodies. The ICH guideline for performing the new pharmaceutical finished product’s stability testing are shown in this review paper.

Keywords: Stability studies, pharmaceutical product, stability zones, ICH guideline, stability testing