CONDUCTING OF STABILITY STUDY

Description

A stability study is a crucial process in the pharmaceutical, cosmetic, and food industries to ensure the safety, efficacy, and quality of products over time. This scientific investigation assesses how environmental factors such as temperature, humidity, light, and storage conditions affect the physical, chemical, and microbiological characteristics of a product. The results are essential for determining the product’s shelf life, appropriate packaging, and storage recommendations.

The process begins with the selection of representative batches of the product, followed by placing them under specified conditions as per regulatory guidelines (e.g., ICH, WHO, or FDA). Regular sampling and testing are performed at predetermined intervals to monitor key attributes like potency, pH, appearance, and stability of active ingredients. These studies are conducted under accelerated and long-term conditions to predict the product’s behavior in various climates.

Meticulous documentation is integral to the process, ensuring traceability and regulatory compliance. Analytical data obtained from the study are analyzed and interpreted to establish the shelf life and storage conditions. This scientific evaluation plays a vital role in product development, regulatory submissions, and maintaining consumer trust by delivering products that meet stringent quality standards throughout their lifecycle.