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

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

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

10% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED LEAD (Pb) AS REPORTED ARSENIC (As) AS REPORTED MERCURY (Hg) AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED HALAL EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST

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

Test Specification Min Max ASSAY (C[@10@]H[@13@]N[@2@]Na[@3@]O[@8@]

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