Stability testing and shelf life determination of ayurveda, siddha and unani medicine

Summary of article contents:

There is an increasing concern for shelf life and stability of Ayurveda, Siddha and Unani Asia over the centuries. Stability is an important parameter for safety and efficacy of product. found in classical texts as well as Drug and Cosmetic Acts (D & C act) and Rules 1945, a person applying for licence or renewal of licence for the manufacturing of patent & proprietary ASU medicines, has to submit scientific data based shelf life or date of expiry of the medicine based on the Real studies to the State Licensing Authority. The API (The Ayurvedic Pharmacopoeia of India) Part I, Vol. VIII prescribe guidelines for stability testing and shelf life determination for new and existing Ayurvedic drugs including Siddha and Unani medicine. The guideline covers scope and objective, general information, selection of batches, container and cl sure system, specification, testing frequency, storage condition and evaluation. on the dosage form packaged in the container and closure system proposed for marketing. Formal stability studies should be conducted on at least three primary batches. The recommended storage conditions for accelerated long term study are 40 0 C ± 2 0 C / 75 % RH ±5 % RH for minimum % RH for minimum of 12 months respectively. A product can be considered to be stable if “no significant change” occurs during at any time of testing. Keywords: Shelf life, Stability, Ayurveda, Unani, Siddha INTRODUCTION Traditional or alternative medicine is widely used in the prevention, diagnosis and treatment of an extensive range of ailments