Abstract

STABILITY STUDIES OF PHARMACEUTICALS DOSAGE FORM

Raja Kumar*, Mrs. Jyoti Kumari*, Rajaram R. Rajbhar*

ABSTRACT

Stability Studies-The cornerstone of Pharmaceutical Product Development An Introduction Abstract. Pharmaceutical stability studies are crucial for guaranteeing that medicinal products remain safe, efficacious and of good quality throughout their entire proposed shelf life. Such studies examine the effect of various environmental factors like temperature, humidity, light, oxygen and storage conditions on the physico-chemical, microbiological, pharmacological and toxicological parameters of pharmaceutical formulations. These studies carried out according to internationally accepted guidelines of ICH and WHO provide scientific basis for establishing the shelf-life of the drug products, their expiry date, optimal packaging material and recommended storage conditions. Several types of stability studies have beenperformed which include long-term, accelerated, intermediate, stress, photo-stability and in-use stability studies to investigate stability of products under varying environmental conditions. Nowadays many analytical techniques like HPLC, GC, LC-MS and UV-Visible spectrophotometry are employed to detect the degradation products andmonitorthe stability of drug product. Stability studies help in the development of new drug formulation, for regulatory approval, quality assurance and in thepostmarketing surveillance activities of drug products to satisfy theinternational guidelines and regulations. Stability testing is the key factor that underpins safe, effective and high-quality products and thus is of immense importance for the well-being of the patient and in promoting the credibility of pharmaceutical manufacturing and the health systems.

Keywords: Pharmaceutical Stability, Stability Studies, Shelf Life, Expiry Date, Accelerated Stability Testing, Long-Term Stability Testing, ICH Guidelines, WHO Guidelines, Drug Degradation, Quality Assurance, Pharmaceutical Products, Storage Conditions, Stability T