Hold time study

Is hold time study required for each & every product ? and also for each & every dispensed material ?

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You can have matrix and bracketing approach to select the worst-case product to conduct Hold time studies. For example, if the API and excipients are the same for different strengths of one product, then you can perform Hold time study of dispensed materials of any one product (as a worst case). However, you will have to justify the selection of that product-strength as a “Worst case”.