Purity Testing of Polysorbate 80

Introduction

Polysorbate 80 is a highly safe water soluble emulsifier that, in addition to its use in ointments (creams) as an emulsifier, is also used as an injectable solubilizing agent for oil-soluble vitamins as well as in health drinks. There was a partial revision of the Japanese Pharmacopoeia (2011 Japanese Ministry of Health, Labour and Welfare Notification No. 65) as reported by the Japanese Ministry of Health, Labour and Welfare in its Notification No. 47 (February 28, 2014), and which became effective that same day. In that Pharmacopoeia Supplement, the section "Purity (2)" was added to the Polysorbate 80 article of the official monographs. This Application News introduces the analyses described in Purity (2), Polysorbate 80 of the official monographs.

June 26, 2015 GMT