Target product profile for misoprostol and mifepristone point-of-care quality testing

This target product profile (TPP) focuses on quality testing of misoprostol as a priority use-case because it is more widely used and distributed than mifepristone, including for medical abortion and postpartum hemorrhage management.

Misoprostol is also chemically less stable, degrading quickly when exposed to heat and humidity, and its low active ingredient content (measured in micrograms) makes accurate quality testing technically challenging. In contrast, mifepristone is more stable and typically manufactured and distributed through more controlled channels.

Therefore, developing a robust, field-appropriate quality testing method for misoprostol addresses a greater public health need and it would pave the way for mifepristone quality testing in the near future.