Test Specification Min Max ASSAY 99% RETEST DATE

Test Specification Min Max ASSAY (C[@7@]H[@8@]O[@3@]); ANHYDROUS BASIS 99.00% RESIDUE ON IGNITION 0.20% WATER 0.50% IDENTIFICATION TO PASS TEST TO PASS TEST CERTIFIED KOSHER CERTIFIED HALAL EXPIRATION DATE

Test Specification Min Max ASSAY (S-H) 99.00% MELTING POINT 38� 44�C OXIDIZED DITHIOTHREITOL 0.50%

Test Specification Min Max NO SPECIFICATIONS

Test Specification Min Max ASSAY 99.0-102.0 % 99.0-102.0 % ALKALINITY TO PASS TEST TO PASS TEST WATER 21.0- 26.0 % 21.0- 26.0 % LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS...

Test Specification Min Max APPEARANCE EXPIRATION DATE

Test Specification Min Max APPEARANCE Off-white lump s Off-white lump s

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% RELATED SUBSTANCES: . . IMPURITY B 0.15% IMPURITY E 0.05% UNSPECIFIED IMPURITIES 0.10 % each TOTAL IMPURITIES 0.30% LOSS ON DRYING...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 172.0� 176 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.10% ELEMENTAL...

Test Specification Min Max APPEARANCE EXPIRATION DATE

Test Specification Min Max ASSAY 97.50% 97.50%

Test Specification Min Max POTENCY 90.0 - 110.0 % 90.0 - 110.0 % ASSAY (DRIED BASIS) 2500 U/mg SOLUBILITY TO PASS TEST MICROBIAL LIMITS TO PASS TEST LOSS ON DRYING...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +72 to +80 +72 to +80 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION...

Test Specification Min Max POTENCY (POLYMYXIN B ; DRIED BASIS) 6,000 U/mg pH of a 0.5% Solution 5 7.5 COMPOSITION OF POLYMYXINS TO PASS TEST TO PASS TEST LOSS ON...

Test 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...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% SULFATED ASH 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50%...

Test Specification Min Max ASSAY (Se) 52 55.50% RESIDUE ON IGNITION 0.20% SOLUBLE SELENIUM COMPOUNDS 5 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +118� to +130� +118� to +130� LOSS ON DRYING 1.50% CHROMATOGRAPHIC PURITY TO PASS TEST ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 91.0 - 100.5 % 91.0 - 100.5 % LOSS ON DRYING 2.00% IDENTIFICATION EXPIRATION DATE

Test Specification Min Max ASSAY (CELLULOSE GUM; DRIED BASIS) 99.5 100.50% DEGREE OF SUBSTITUTION (CARBOXYMETHYL GROUPS PER ANHYDROGLUCOSE UNIT; DREID BASIS) 0.2 1.5 LEAD 2 mg/kg LOSS ON DRYING 10.00%...

Test Specification Min Max ASSAY (C[@9@]H[@11@]NO[@2@]; DRIED BASIS) 98.5 101.50% LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.30% IDENTIFICATION TO PASS TEST EXPIRATION DATE

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% CHLORINE 0.60% SULFATES 0.01% MAGNESIUM AND ALKALINE-EARTH METALS...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0-100.5 % 99.0-100.5 % WATER 32.0- 37.0 % 32.0- 37.0 % LEAD (Pb) 2 mg/kg SELENIUM (Se) 0.00% IDENTIFICATION TO PASS TEST TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0 - 102.0% 98.0 - 102.0% OPTICAL ROTATION +84.0� to +87.5 +84.0� to +87.5 LEAD (Pb) 1 mg/kg METHANOL 0.10% HYDROLYSIS PRODUCTS TO...

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY (DRIED BASIS) 96.0 - 100.5 % 96.0 - 100.5 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.50% FREE IODINE AND IODIDE: IODINE TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 10.4 12.40% HEAVY METALS 20 ppm ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST...

Test Specification Min Max SAPONIFICATION VALUE 40 50 HYDROXYL VALUE 96 108 WATER DETERMINATION 3.00% PEROXIDE VALUE 10 ACID VALUE 2 RESIDUE ON IGNITION 0.25% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 103.00% pH 4.1 4.5 WATER DETERMINATION 18 26.50% INSOLUBLE SUBSTANCES 0.20% CHLORIDE 0.01% SULFATE 0.15% ALUMINUM, CALCIUM, AND RELATED ELEMENTS TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) SODIUM CETOSTEARYL SULFATE 90.00% 90.00% SODIUM CETYL SULFATE 40.00% 40.00% ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST SODIUM CHLORIDE AND SODIUM...

Test Specification Min Max ASSAY 99% 99%

Test Specification Min Max ACID VALUE 204 - 220 204 - 220 SAPONIFICATION VALUE 205 - 221 205 - 221 TITER (SOLIDIFICATION POINT) 53.3 - 62 C 53.3 - 62...

Test Specification Min Max APPEARANCE EXPIRATION DATE

Test Specification Min Max APPEARANCE EXPIRATION DATE