Analysis of Ethanol and Anhydrous Ethanol in Accordance with the Fifteenth Edition of the Japanese Pharmacopoeia

Introduction

The Japanese Pharmacopoeia is a compendium of standards for drugs that was established in accordance with the Pharmaceutical Affairs Law. The fifteenth edition came into effect on 1 April 2006. Regarding the differences between this edition and the fourteenth edition, although no changes were made to the “Infrared Spectrophotometry” item that appears under “General Tests, Processes and Apparatus”, the infrared spectra for 29 of the items listed under “Official Monographs”, including ethanol, anhydrou ethanol, and acrinol hydrate, were added to “Infrared Reference Spectra”. Accordingly, additions or modifications have been made to the identification tests specified for these items, and identification using infrared spectrophotometry is now required. Examples of the analysis of ethanol and anhydrous ethanol, for which the fifteenth edition of the Japanese Pharmacopoeia requires that identification tests are performed using infrared spectrophotometry, are presented here.

September 5, 2007 GMT