Shelf Life Estimation of Pharmaceutical Products
All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts 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.
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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 the pharmaceutical products and substances. Shelf life is determined by the evaluation of whole stability data of the product.
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