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Shelf Life Testing — Product Efficacy of API & Finished Drug Products

The Federal Drug and Food Administration (FDA) states that “Stability studies should include testing of those attributes of the active substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The justification of individual and total upper limits for degradation products should be based on safety and/or efficacy consideration.”

Safety, quality, and product efficacy work together in stability studies of Active Pharmaceutical Ingredients (APIs) and finished drug products. Through stability testing, pharmaceutical companies like Alcami have the ability to identify and trend shelf life and their effects on efficacy as samples are exposed to time, light, and temperature.

In order to learn why consistent shelf life testing is so important in establishing efficacy, you must first understand these definitions: 

Stability studies definitions

The FDA regulates API and finished drug product efficacy, and both must demonstrate effectiveness to gain approval. In finished products, stability storage and testing are taken into consideration. Stability storage and testing demonstrate how products withstand degradation when exposed to varying temperatures, humidity, and light.

All finished products approved by the FDA have established levels of efficacy, and potency can significantly impact side effects. For instance, a drug may have very good efficacy but is so unpleasant to take, due to side effects and amount of degradation, that its actual effectiveness within the margin of safety is extremely limited. With stability storage and testing, we are able to identify these potential issues.

In-use stability studies, the inherent stability characteristics of the molecule, particularly the degradation pathways, must be identified. Degradation correlates with the effectiveness and the efficacy of the finished product in order to measure the shelf life of a product.  Scientists are able to identify the degradation in the product form and the suitability of analytical procedures for the quantification of both the active substance and degradation products to establish retest periods. Thus, stability studies are ultimately determining the shelf life of the finished product.

A shelf life determines a timeline for when a product is considered safe and effective under relevant storage conditions. Such factors as temperature and relative humidity can be used to accelerate these processes effectively allowing for trending and prediction of shelf life.

Fundamental degradation factors involving the efficacy and shelf life of APIs/finished drug products are listed below: 

Fundamental degradation stability factors involving the efficacy and shelf life of APIs/finished drug products

There are provisions in place regarding the particular formulation, as well as the container, to remain within particular chemical, microbiological and physical specifications as guided in the International Conference on Harmonisation (ICH) to ensure maximum efficacy and safety of the product.

Thank you for your interest in learning more about stability. Alcami offers stand-alone stability services as well as in-process studies with the expertise to guide you from the design of the stability study for each phase of development through the evaluation of the data accruing to ICH Q1E. 

1              Medbullets Team 2017 “Efficacy vs. Potency”
2              Medilexicon, 2017, MediLexicon International Ltd, Brighton, UK  “Effectiveness”
3              American Heritage® Dictionary of the English Language, Fifth Edition. Copyright © 2016 by Houghton Mifflin Harcourt Publishing Company. Published by Houghton Mifflin Harcourt Publishing Company. All rights reserved.
4              FDA (1987). Guideline for submitting documentation for the stability of human drugs and biologizes. Rockville, Maryland: Food and Drug Administration, Center for Drug and Biologizes, Office of Drug Research and Review.

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