Accelerated stability testing increases the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing program. This data along with real-time stability studies are used to assess longer-term chemical effects under non-accelerated conditions.

Accelerated stability testing may be completed on one batch in order to establish a tentative expiration date. Using the data from accelerated testing to establish a tentative expiration dating period of greater than three years is discouraged when it’s based only on accelerated data[1]. Data should be combined with room temperature data to justify an expiration dating period of over two years.

Storage conditions for accelerated stability testing are usually 40°C with a relative humidity of 75%. A significant change is considered to have occurred if the assay value shows a 5% decrease compared to the initial assay value, any specified degradation product is present and greater than the specification limits, the pH limits for the product are no longer met, the specification limits for the dissolution of capsules or tablets are no longer met, the specification for appearance and physical properties are no longer met[2].

Accelerated testing can allow your product to have an interim expiration date while real-time testing is still occurring. If your company needs assistance with any form of stability testing, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.


[1] FDA (November, 2014) Expiration Dating and Stability Testing for Human Drug Products. Retrieved on April 4, 2022 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/expiration-dating-and-stability-testing-human-drug-products

[2] World Health Organization (1996) Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms. Retrieved on April 4, 2022 from https://www.paho.org/hq/dmdocuments/2008/6_Annex_5_report_34.pdf

Emma International

Emma International

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This