ACCELERATED STABILITY TESTING OF DOSAGE FORMS AS PER INTERNATIONAL CONFERENCE OF HORMONIZATION (ICH) GUIDELINES
Dr A. Sambasivarao, Dr. Chandra Sekhara Rao Baru, M. Hareesh Reddy*
ABSTRACT
Objectives of accelerated stability studies are linked to the establishment assurance of safety, quality and efficiency of drug product from early phase development through the drug product. The stability data for the drug substance are used to determine optimal storage and packaging conditions for bulk lots of material. In order to assess stability, the appropriate physical, chemical, biological and microbiological testing must be performed. Pharmaceutical companies estimate the shelf life (Expiration date) of a drug in order to determine the amount of time the drug is at acceptable potency, color, etc., levels. The pharmaceutical company or the food and drug administration set the acceptable levels. The process in which the shelf-life is determined is called a stability analysis. During the shelf-life, a drug can stay on the shelf without degrading to unacceptable levels.
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