Protamine Sulfate USP EP Surfactant Chemicals Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE AS REPORTED AS REPORTED ASSAY (FREE SO[@3@]) 18 - 24% 18 - 24% SULFURIC ACID EQUIVALENT 104

7962 UV ABSORPTION TO PASS TEST TO PASS TEST VOLATILE IMPURITIES TO PASS TEST TO PASS TEST NONVOLATILE RESIDUE TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST CLASS 2 (SOLVENT) / METHANOL 3000 ppm CLASS 3 (solvent) / 1-PROPANOL 5000 ppm CLASS 3 (solvent) / 2-PROPANOL 5000 ppm

99% APPROX

Test Specification Min Max ASSAY 99% MELTING POINT 108 - 113 C 108 - 113 C

Protamine Sulfate USP EP Surfactant Chemicals Test Specification Min Max APPEARANCETest Specification Min Max APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ASSAY (DRIED BASIS) 90 110. 00% CHROMATOGRAPHIC PURITY 92% NITROGEN 21 26. 00% SULFATE (DRIED BASIS) 16 22% ULTRAVIOLET ABSORBANCE TO PASS TEST TO PASS TEST LOSS ON DRYING 5% IRON 10 ppm MERCURY 10 ppm METHYLMERCURY 10 ppm BACTERIAL ENDOTOXIN 7. 0 USP EU ELEMENTAL IMPURITIES CADMIUM 0. 2 ug g LEAD 0. 5 ug g INORGANIC ARSENIC 1. 5 ug g INORGANIC MERCURY 0. 3 ug g NICKEL 2 ug g