Shelf Life Determination of Pharmaceutical Products
All pharmaceutical drugs degrade with time forming the by-products. These by-products may harmful to the health of the patients consuming the drug. The shelf life of the pharmaceutical products is the time period for which the product maintains its identity and quality when stored at the conditions defined on the label of the product.
It is important to set the time frame to consume the pharmaceutical products. ICH Q1E guideline provides guidance for the estimation of the shelf life of pharmaceutical products and substances. Shelf life is determined by the evaluation of the whole stability data of the product.
Minimum data of three batches are used to estimate the shelf life of pharmaceutical products. For the products stored at room temperature, the assessment should be started from the occurrence of the significant change in product stored in accelerated conditions. If no significant change is found in the accelerated conditions then shelf life would depend upon the long-term storage conditions data.
Shelf Life Chart
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