p-Dioxane HPLC Grade Emulsifying Agent Excipients Test Specification Min Max ASSAY

Test Specification Min Max ASSAY 98 - 101 % 98 - 101 %

00% FREE ACID (H[@2@]SO[@4@]) 0

50% SPECIFIC ROTATION [a][@D@] +26

10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE APPEARANCE DATE OF MANUFACTURE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

5 % INSOLUBLE MATTER 0

p-Dioxane HPLC Grade Emulsifying Agent Excipients Test Specification Min Max ASSAYTest Specification Min Max ASSAY (C[@4@]H[@8@]O[@2@]; by GC) 99. 70% COLOR (APHA) 20 FREEZING POINT 11. 0?? ULTRAVIOLET ABSORBANCE (1 cm cell vs. water) TO PASS TEST TO PASS TEST RESIDUE AFTER EVAPORATION 5 ppm TITRABLE ACID 1. 6 ueq g CARBONYL (as HCHO) 0. 01% PEROXIDE (as H[@2@]O[@2@], AT TIME OF PACKG.) 0. 01% WATER 0. 05% RETEST DATE