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14.07.2020 - Pharmacy

Opened-pack stability testing of pharmaceuticals

For pharmaceuticals, the shelf life is indicated in the form of an expiration date. In contrast to pharmaceuticals in blister packaging, pharmaceuticals for multiple use, such as tubes or glass containers, should only be used for a limited time after opening. Reasons for this include microbial contamination upon contact with the skin. Furthermore, repeated opening can cause a reaction of air oxygen, moisture, and light with the contents.

Based on open-container stability studies of pharmaceutical preparations in multi-dose containers, the shelf life (conducted on two different batches) is demonstrated after initial opening. It is advisable to conduct the testing of a batch at the beginning as well as at the end of the specified shelf life. The CPMP Guideline CPMP/QWP/2934/99 of the EMA (European Medicines Agency) lays down the requirements for open-container stability studies.

Do you have questions about the testing of the open-container stability of pharmaceuticals or would you like to make use of our services?

The BAV Institute, as part of the international Tentamus Laboratory Group, is very happy to support you with this.