Analysis of Fatty Acid Content Ratios in 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 this Pharmacopoeia Supplement, the section "Composition of fatty acids" was added to the Polysorbate 80 article in the official monographs. A system suitability test has been established for this test method, and the system must conform to the test requirements. Regarding the actual sample analysis, the product is to be dissolved in sodium hydroxide, and when conducting gas chromatographic analysis of the sample solution derivatized with boron trifluoride-methanol reagent, the required fatty acid content ratios have been specified as: myristic acid 5.0 % or less, palmitic acid 16.0 % or less, palmitoleic acid 8.0 % or less, stearic acid 6.0 % or less, oleic acid 58.0 % or less, linoleic acid 18.0 % or less, and linolenic acid 4.0 % or less. This Application News introduces the system suitability test associated with the analysis of fatty acid content ratios specified in Polysorbate 80 in the official monographs.

June 25, 2023 GMT