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Shelf Life Estimation of Pharmaceutical Products

Learn how the shelf life of the pharmaceutical products and substances is determined according the ICH guidelines for stability testing.
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.

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.

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.

If long-term and accelerated conditions data show very little change or no change at all then it might be assumed that the product would be stable during the proposed shelf life period.

In this case, there is no requirement of the statistical analysis and the justification for the same should be given. In this case, the shelf life of the product can be proposed twice but should not be more than 12 months of the period covered by the long-term evaluation data.

If long-term condition or accelerated condition data shows change then statistical analysis is used to estimate the shelf-life of the drug product. When the statistical calculations cannot be done by the data, the shelf life period can be defined 1.5 times of the period covered by the long-term data.

When the data is sufficient for the statistical calculations shelf-life would be defined double but not more than 12 months from the period covered by the long-term data. Details can be read in ICH Q1E guidelines.

Figure: Layout for the Process of Determination of the Shelf Life of the Pharmaceutical Products.

Shelf life estimation

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

2 comments: Post Yours! Read Comment Policy ▼

  1. Why the intermediate stabilility testing condition was negeleted from the testing of dosage forms during their stability.

    Naresh Babu

  2. If long term stability failure at 36 months of a product which shelf life is 24 months, is OOS required to investigate the failure


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