Tobramycin Sulfate USP Sulfonium Compounds Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (C[@14@]H[@30@]O) 97% 97% MELTING POINT 38 - 40 C 38 - 40 C

50% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST

Test Specification Min Max RHENIUM 995 - 1005 ppm 995 - 1005 ppm STANDARDIZED AGAINST NIST 3143 3143 EXPIRATION DATE

Test Specification Min Max ACID VALUE 3 SAPONIFICATION VALUE 165 - 175 165 - 175 IODINE VALUE 3 RETEST DATE

000001 IRON (Fe) 0

Tobramycin Sulfate USP Sulfonium Compounds Test Specification Min Max ASSAYTest Specification Min Max POTENCY (C[@18@]H[@37@]N[@5@]O[@9@]) 634 739 g mg pH 6 8 WATER DETERMINATION 2. 00% RESIDUE ON IGNITION 1. 00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST