WHO Drug Information Vol. 30, No. 1, 2016

Quality of misoprostol products

Introduction: This article presents findings from testing of misoprostol samples, specifically with regard to the percentage of labelled content of active ingredient over time in products packed in different types of blister packs, and makes recommendations for national regulatory authorities and for procurement organizations.

Summary

  • - Four out of every ten samples contained less than 90% of the labelled content of misoprostol.
  • - None of the 50 samples packed in a plastic/alu blister was within specifications after one year.
  • - Misoprostol packaged in an alu/alu blister pack is not a guarantee of a stable product – 28% of the alu/alu samples showed degradation.
  • - There was no evidence that 14 samples had ever contained misoprostol, three of these were falsified products labelled as Cytotec®.
  • - Only one of 48 samples of products that had passed a stringent assessment had a labelled content of misoprostol below specifications.

Comment:Comment/advice: When using misoprostol products for safe abortion, or for prevention of postpartum hemorrhage, one must try to use a product that is registered by a stringent regulatory agency and/or has been PreQualified by the WHO. (see: http://apps.who.int/prequal/query/ProductRegistry.aspx) Never use a product that is not packaged in double aluminium blister, since alu/plastic blister does not protect against humidity and will therefore lead to loss of activity. (HMV)