Hold Time Study in Pharmaceutical Manufacturing
Sampling Intervals for Hold Time Study:
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sir its really a very valuable information. but could you please explain what should be the plan for finished formulation not charged in stability chamber for 4-5 months. how to justify this hold time.
Hi, if more than 2 months of finished product complication, send for sample and analyzed as per stability specification and it can be concede as initial interval analysis.
why and when the full bled is hold for study. what is the criteria for selection of strength and which strength higher or lower is taken? how many batches are required to be kept for hold time study??
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