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[RegAffairs]Re: Query on stability studies
Dear Luv Wadhwani, Investigation to the failure to be conducted as a preliminary action, which i think might have done from your end. then basing on the stability study the storage conditions to be reassessed and basing on this you may provide the shelf life and the storage conditions. I would also like to know if you have the stability studies conducted at 5±3°C and 25±2°C, if so this can also help you to evaluate the situation. Regards anil kumar singh |
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