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
