Challenges on USP-JP Harmonization from Pilot Project on Drug Substances and Drug Products Monographs

Abstract

 Due to the globalization of the supply chain of pharmaceutical substances and products, the importance of harmonization of pharmacopoeias is increasing. Therefore, the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) bilaterally work on harmonization of “Dapagliflozin Propylene Glycol Hydrate” and “Dapagliflozin Propylene Glycol Tablets” monographs. In the current JP drafts, the main points that have been harmonized are (1) describing concentration (instead of weight) in the test procedure, (2) application of＜2.00＞chromatography, and (3) no Ultraviolet-visible spectroscopy in the identification. The main points that can’t be harmonized are the content specifications of the tablet, dissolution, and system suitability. It is believed that the completion of this project and the harmonization of the monographs between the JP and USP pharmacopoeias will reduce the burden on stakeholders and contribute to the supply of high-quality medicines.