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Re: stability testing
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Answer: No (But protocol need to be followed) probable plan may be: Intervals : 3, 6, 9, 12, 18, 24, 36 BET : All intervals Particulate matter: All intervals Sterility: 24, 36 only Note: It is advisable to carry container closure integrity test where sterility test is skipped. It is advisable to carry “Particulate matter” in all intervals as contributing factors for this are many. (Physical, chemical & microbiological). There is a strong reason for not carrying BET at all intervals as there are no contributing factors for endotoxins in a finished product, if container closure integrity is not compromised. Normally is it is carried at all intervals. It is also important to consider the batch size or quantity of stability samples to prepare a protocol such that you arrive at maximum data with least number of samples and intervals. Regards, RAJANEESH.BR brrajaneesh@gmail.com -------------------------------------------- Rajaneesh.br brrajaneesh@gmail.com NA -------------------------------------------- |
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