Template-Type: ReDIF-Article 1.0
Author-Name: Sarvesh Tiwari
Author-Workplace-Name: Scholar, Department of Pharmaceutics, School of Pharmacy, YBN University, Ranchi, Jharkhand, India
Author-Name: Subarna Kumar Mandal
Author-Workplace-Name: Assistant Professor, Department of Pharmaceutics, School of Pharmacy, YBN University, Ranchi, Jharkhand, India
Author-Name: Ashish Sarkar
Author-Workplace-Name: Dean, School of Pharmacy, YBN University, Ranchi, Jharkhand, India
Title: Stability Assessment of Pharmaceutical Products Under Accelerated Conditions
Abstract: An essential aspect of developing a pharmaceutical product is performing a stability assessment to ensure that the drug will be safe, effective, and perform as expected during its shelf life. To help predict long-term stability of pharmaceutical products, accelerated stability studies are frequently used by placing drug products under high temperature and humidity conditions for a predetermined period of time. The objective of the study was to evaluate the stability of pharmaceutical products stored under accelerated conditions in accordance with the International Council for Harmonisation (ICH) guidelines. Representative batches of the formulation were put into the appropriate container-closure system and stored at 40 ± 2 degrees Celsius and 75 ± 5 percent relative humidity (RH) for six months. Samples of the products were taken from the test conditions at pre-specified time points and analyzed for critical physical and chemical properties such as appearance, assay, dissolution, moisture content, pH, hardness, friability, and impurity profile. Based on the analysis results, all formulations remained within acceptable pharmacopoeial specifications for the duration of the study with minimal variations observed in physicochemical properties. The lack of significant degradation of the products or change in potency indicates sufficient stability at accelerated conditions. Accelerated stability studies yield useful information about predicted shelf-life, required storage conditions and suitability of packaging for pharmaceutical products. Furthermore, accelerated stability studies are important tools in providing quality assurance and regulatory compliance for developing stable and effective pharmaceutical formulations with predictable long-term performance.
Keywords: accelerated stability studies, pharmaceutical products, ICH guidelines, shelf life, drug degradation, relative humidity
Journal: Inventum Biologicum: An International Journal of Biological Research
Pages: 14-20
Volume: 6
Issue: 3
Year: 2026
File-URL: https://journals.worldbiologica.com/ib/article/view/219
File-Format: text/html
File-URL: https://journals.worldbiologica.com/ib/article/view/219/387
File-Format: Application/pdf
Handle: RePEc:adg:ibijbr:v:6:y:2026:i:3:p:14-20