RE: rahul Contribution from T.R.Narayanappa written on 7/16/2008 at 12:08
Original contribution: rahul written by gagandeep kaur on 7/11/2008 at 09:36) Normally stability study will be performed one station morethan anticipated retest/shelflife. This is to cover up shipment and distribution duration as well as to have enough data in case of extension of shelflife in the event product is performing well even after shelf life.
With respect to no of tablets/capsules required for stability, please calculate how many tablets/capsules required to cover all the tests as per your stability protocol at each time point and collect sufficient tablets/capsules. Always keep sufficeint samples required to carry out two analysis in both accelerated and long term storage condition as standby samples which you may require for the investigation of OOS/OOT at any time point during stability study. Apart from this please keep tablets/capsules sufficient to carryout two analysis as control samples.
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