The
concept of stability is one of the most important issues regarding Ayurvedic
formulations as till date no specific
guidelines are available for the same. Although the Ayurvedic lexicon as well as Gazette notification
issued by Government of India on 26th November, 2005 revealed shelf life of Ayurvedic
formulations but greater advancements in packaging and storage technology now-a-days has
created a need for the revision of their shelf life. Mainly, two guidelines namely ICH
(International Conference on Harmonization) and WHO (World Health Organization)
provide details regarding parameters for stability study of pharmaceutical
products but ICH
guidelines from Q1 to Q11 is generally followed. A well designed stability
protocol containing information
like Selection of Batches and Samples, Test Attributes, Analytical Procedures, Acceptance Criteria,
Storage Conditions and period, Testing Frequency, Sampling plan, Container Closure System
etc, various types of stability study and stability testing methods should be
taken into consideration. Currently pharmaceutical product are generally
assayed using a validated stability indicating analytical method and an expiry
date is marked based on the predicated period from date of manufacture when the
pharmaceutical product would show more than 10% deterioration in the active
molecule. So, these guidelines may also be implemented on Ayurvedic
formulations where percentage degradation can be assayed when the product is
stored at different conditions of temperature and humidity. The general concept
of stability for Ayurvedicor modern medicine remains same but the parameters
used to assess the stability may vary from product to product.
Author(s) Details
Dr. Chinky Goyal
Department of Rasa Shastra and Bhaishjya Kalpana, Shri Dhanwantry Ayurvedic College and Dabur Dhanwantry Hospital, Sector-46 B, Chandigarh, India.
Dr. Gupta Arun Kumar
Department of Panchkarma, L.N. Ayurveda College and Hospital, Bhopal, Madhya Pradesh, India.
View Book :- http://bp.bookpi.org/index.php/bpi/catalog/book/192
Author(s) Details
Dr. Chinky Goyal
Department of Rasa Shastra and Bhaishjya Kalpana, Shri Dhanwantry Ayurvedic College and Dabur Dhanwantry Hospital, Sector-46 B, Chandigarh, India.
Dr. Gupta Arun Kumar
Department of Panchkarma, L.N. Ayurveda College and Hospital, Bhopal, Madhya Pradesh, India.
View Book :- http://bp.bookpi.org/index.php/bpi/catalog/book/192
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