Hold time study

What will be the quantity of tab/cap/PFS (at least) to be hold to perform hold time study? And which type of container will be used to hold the product ?

For hold time study the quantity of tablets. capsules or any material should be sufficient to conduct the analysis/testing of those items as per the frequencies defined in the ‘Hold time’ protocol (some additional quantity should be kept to repeat analysis/testing if required.
The containers to be used for the hold time study should be of the same construction material (such as Stainless steel, High or low-density polyethylene, glass, fibre drum etc.). The size of containers should be appropriate to the quantities of materials taken for hold time studies. It is to be ensured that the head space in the containers should be the same as that of real conditions maintained during the actual production of that drug product.
Also, it is to be ensured that the storage conditions (such as temperature, relative humidity, light, etc.) are the same as those followed during routine production & storage of the materials & the products.

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