Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS...

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 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 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) 97.5 101.00% DIASTEREOISOMER A CONTENT 45 55.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10%...

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 (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 ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 2.00% ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 2.50% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION -16.7� to -22.7 -16.7� to -22.7 pH OF A 0.1% SOLUTION @ 20[dC 4.4 5.4 LOSS ON DRYING 4.00%...

Test Specification Min Max ASSAY (DIPHENHYDRAMINE; DRIED BASIS) 53 55.50% ASSAY (8-CHLOROTHEOPHYLLINE; DRIED BASIS) 44 47.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.30% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: LEAD (Pb) AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% MELTING RANGE 162 165�C SPECIFIC ROTATION [a][@D@](C=0.04;water) -1.0 to +1.0� -1.0 to +1.0� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.04% SELENIUM (Se) 30 ppm ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ACIDITY (as ACETIC ACID) 0.30% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20%...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% (Z)-ISOMER 13.6 18.10% (E)-ISOMER 81.4 88.20% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% CLARITY AND COLOR OF SOLUTION CLEAR AND COLORL CLEAR AND COLORL LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% IRON (Fe)...

Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -50.0� to -54.0 -50.0� to -54.0 LOSS ON DRYING 2.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST PHOSPHORUS 100 ppm RESIDUE ON IGNITION 0.10% WATER DETERMINATION 12.00% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% HYDRAZINE 10 ppm ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0 - 101.0 % 98.0 - 101.0 % MELTING RANGE 47� - 52� C 47� - 52� C WATER 0.50% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% MELTING RANGE 99� 103�C LOSS ON DRYING 0.50% RESIDUE AFTER IGNITION 0.10% RELATED COMPOUNDS AS REPORTED INDIVIDUAL 0.30% TOTAL 1.00% ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH 3.5 5 LOSS ON DRYING 1.00% ORGANIC IMPURITIES, PROCEDURES 1 AND 2 TO PASS TEST TO PASS TEST RESIDUE ON...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % MELTING RANGE 170 - 173 C 170 - 173 C pH OF A 10% SOLUTION...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% E-ISOMER 0.30% IRON (Fe) 0.01% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY 30 38.00% ALUMINUM CONTENT 15.5 18.50% CLARITY AND COLOR OF SOLUTION CLEAR AND CLEAR AND ACID NEUTRALIZING CAPACITY 12 mEq CHLORIDE (Cl) 0.50% ARSENIC (As)...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% pH OF A 1 IN 50 SOLUTION 3 4.5 COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% RESIDUE AFTER...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 165� 169�C LOSS ON DRYING 0.30% RESIDUE ON IGNITION 0.10% FREE p-AMINOBENZOIC ACID 0.10% ORDINARY IMPURITIES 2.00% ELEMENTAL IMPURITIES...