stability testing

As per PCI Syllabus

1. Stability Testing of Herbal Drugs S.Selvadurai.,M.Pharm.,MBA ., Associate Professor Department of Pharmacognosy

2. Advantages Help in determination of shelf life and storage conditions. Help in selection of suitable formulation, excipients and container closure systems for a product. Well being of the patient and manufacture by ensuring the good product quality. Enhance patient confidence in herbal drugs and improve compliance.

3. Types of stability study as per usp S.No Type of Stability Condition to be maintained throughout the shelf life of drug product 01 Physical The original physical properties, namely, appearance, uniformity, dissolution & suspendability are maintained. 02 Chemical Each & Every active ingredient retains its chemical integrity as well as potency specified on lable , within the specified limits. 03 Microbiological Sterility or resistance to microbial growth is maintained as per the specified requirements 04 Therapeutic The therapeutic effect remains unaltered 05 Toxicological No valid increase in toxicity occurs

4. Specifications criteria for herbal drugs

5. Different stability testing method 01 02 03 04 05

6. Protocol for stability Testing

7. Recommended stability test for different herbal dosage forms according to WHO

8. Factors affecting stability of natural medicines

9. Issues related to stability of herbal drugs