The Japanese Pharmacopoeia participates in the Pharmacopoeial Discussion Group (PDG) to work on pharmacopoeial harmonization of general chapters and pharmaceutical excipient monographs among three pharmacopoeias: the European Pharmacopoeia (EP), the U. S. Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP). Recently, EP and USP had launched on the pilot project to harmonize active pharmaceutical ingredients (APIs) out of PDG scope. JP needed to examine various systematic and technical problems related to the harmonization activities of APIs and established a new expert working group (EWG) under the JP Expert Committees to discuss Montelukast Sodium which was one of the APIs that EP and USP had worked to harmonize. The JP draft monograph of Montelukast Sodium was developed to harmonize with the EP/USP monographs.
This draft monograph of Montelukast Sodium differs from the regular JP draft monographs. The test conditions and requirements such as system suitability, reference standards, and the purity tests such as related substances are not necessarily specified in a way to comply with the Guideline for drafting The Japanese Pharmacopoeia, Seventeenth Edition, for example. This draft monograph of Montelukast Sodium is published for public notice, review, and comment independently from other JP monographs.
The guide for comment is available with a form on the Japanese version of JP website. The comments in Japanese submitted no later than the deadline will be considered for the final version of the monograph.