Beneo is very pleased to announce that with the 17th edition of the Japanese Pharmacopoeia (JP) for
Beneo is very pleased to announce that with the 17th edition of the Japanese Pharmacopoeia (JP) for the first time a monograph for isomalt is now included in the JP.
Isomalt has already been monographed in the Pharmacopoeias Ph. Eur., USP-NF, BP as well as in the “Japanese Pharmaceutical Excipients” (JPE) Quality Standard. In order to establish a monograph in the Japanese Pharmacopoeia, Beneo actively contributed in such a development with the relevant Japanese Institutions for a couple of years.
The new 17th edition of the Japanese Pharmacopoeia is dated on 7 March 2016 and in most parts applicable from 1 April onwards. In the Preface to the JP 17th edition, the newly addition of isomalt, referred to as Isomalt Hydrate, to the Official Monographs is announced.
Currently, the JP 17th edition is only available in Japanese (except Preface), while the translation of the text to English is in progress.
The isomalt monograph in the 17th edition of the JP corresponds to a very large degree with the monographs of isomalt in Ph. Eur. and USP-NF. Not internationally harmonized parameters do include optical rotation and heavy metals (as lead) and are included in the galenIQTM specifications already - as they were relevant for the JPE as well.
Beneo-Palatinit is currently in the progress of reviewing its galenIQTM product documentation to align it with this positive new achievement for galenIQTM/isomalt in the Japanese Pharmacopeia.