JP- and EP-Compliant Analysis of Impurities of COVID-19 Drug Dexamethasone

Introduction

In July 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the anti-inflammatory drug dexamethasone as a drug for treatment of the infectious disease COVID-19 caused by the novel coronavirus (1). Dexamethasone is the second officially-approved COVID-19 drug in Japan. Dexamethasone is a steroid drug that is used with a variety of diseases, including severe infections and interstitial pneumonia, and is already a widely-used drug. It has been reported that administration of dexamethasone also reduced the death rates of COVID-19 patients that required mechanical ventilators or oxygen inhalation in large-scale clinical research in the United Kingdom. Procurements of drug substances and pharmaceutical additives from overseas and shipments of manufactured drugs to other countries are increasing, but the standards and test methods for dexamethasone differ depending on the applicable pharmacopoeia. Therefore, testing conforming to the test method recognized in the destination country is necessary when shipping to other countries. This article introduces analyses based on the test requirements for impurities of dexamethasone in the Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (EP).

November 18, 2020 GMT