Dear Friends
Hold Time Study shall be performed for API and its intermediate.
The purpose of the study to established the self life of API and intermediates are as following
- Intermediates or API remains stable before processing to the next stage
- API should meet the finished product specification criteria.
Hold Time Study shall be performed for API and its intermediate.
The purpose of the study to established the self life of API and intermediates are as following
- Intermediates or API remains stable before processing to the next stage
- API should meet the finished product specification criteria.
In ICH there where no specific requirements or recommendation. Recently one WHO draft guideline has been under approval process which is written by Dr. A.J. VanZyl. The title of document is GENERAL GUIDANCE FOR INSPECTORS ON "HOLD-TIME" STUDIES.
As per guideline, bulk products should not be stored for period of 25% or more of the approved shelf-life unless these are tested with stability indicating methods prior to packing into the final containers.
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