A harmonized test was agreed for Polysorbate 80 in the three pharmacopoeias of Japan, Europe and the United States. Based on this agreement, test methods were revised in Supplement 2 of the Japanese Pharmacopoeia (JP16), 16th Edition, and analysis using gas chromatography (GC) was added.
In accordance with Supplement 2 of the Japanese Pharmacopoeia, 16th Edition, a purity test and fatty acid content ratio test were conducted. Excellent results were obtained.