Test Specification Min Max ASSAY (DRIED BASIS) 93 100.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.50% FREE IODINE AND IODIDE: TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED RESIDUAL SOLVENTS...

Test Specification Min Max POTENCY 800 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH 3 5.5 WATER DETERMINATION 3 6.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO...

Test Specification Min Max MELTING RANGE 174?? 179?? SPECIFIC ROTATION OPTICALLY INACTI OPTICALLY INACTI APPEARANCE OF SOLUTION TO PASS TEST NONVOLATILE RESIDUE 0.05% HALOGENS 0.04% ELEMENTAL IMPURITIES AS REPORTED AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.00% 102.00% X-RAY DIFFRACTION CONFORMS CONFORMS ACIDITY TO PASS TEST ALKALINITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE...

Test Specification Min Max ASSAY 98.0 - 102.0 % 98.0 - 102.0 % MELTING RANGE 116??- 121?? 116??- 121?? pH 4.6 - 5.1 4.6 - 5.1 LOSS ON DRYING 0.50%...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 +96.0??to +100. +96.0??to +100. WATER DETERMINATION 0.30% RESIDUE OF IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC ROTATION -0.2??to +0.2??/td> -0.2??to +0.2??/td> pH 5.5 6.5 WATER DETERMINATION 0.50%...

Test Specification Min Max POTENCY 390 ??/mg 390 ??/mg pH 6.5 - 8.5 6.5 - 8.5 LOSS ON DRYING 7.00% HEAVY METALS 0.00% FREE COLISTINE TO PASS TEST TO PASS...

TestSpecificationMinMaxVISUAL TRANSITION INTERVALSpH7.4 (yellow)pH7.4 (yellow)

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +208??to +217??/td> +208??to +217??/td> LOSS ON DRYING 1.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ORGANIC IMPURITIES TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% pH OF A 1 IN 20 SOLUTION 6.3 9.6 WATER 7.00% FLUORIDE (F) 0.01% ARSENIC (As) 3 ppm LEAD (Pb) 0.00%...

Test Specification Min Max ASSAY (ALKALOIDS of BELLADONNA LEAF) 27 33 mg/100 ALCOHOL DETERMINATION 65 70.00% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE RESIDUAL SOLVENTS TO PASS TEST...

Test Specification Min Max ASSAY (ALKALOIDS of BELLADONNA LEAF) 1.15 - 1.35 % 1.15 - 1.35 % IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE RESIDUAL SOLVENTS TO PASS...

Test Specification Min Max POTENCY (DRIED BASIS) 65 U/mg COMPOSITION OF BACITRACIN TO PASS TEST TO PASS TEST pH OF A 10,000 U/ml SOLUTION @ 25?? 5.5 7.5 LOSS ON...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +75??to +82??/td> +75??to +82??/td> CHROMATOGRAPHIC IMPURITIES TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +99??to +105??/td> +99??to +105??/td> WATER DETERMINATION 10.00% PHOSPHATE IONS 1.00% FREE BETAMETHASONE 1.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION...

Test Specification Min Max ASSAY (BENZOYL PEROXIDE) 70 80.00% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...

Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST EPIMER A TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% pH of a 1 in 4 Solution 0.8 1.2 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +88??to +94??/td> +88??to +94??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...

Test Specification Min Max POTENCY (DRIED BASIS) 65 U/mg COMPOSITION OF BACITRACIN TO PASS TEST TO PASS TEST pH OF A 10,000 U/ml SOLUTION @ 25?? 5.5 7.5 LOSS ON...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 100.5% 98.0 - 100.5% MELTING RANGE 141??- 148?? 141??- 148?? LOSS ON DRYING 5.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% SULFATED ASH 0.10% HEAVY METALS 10 ppm RELATED SUBSTANCES TO PASS TEST TO PASS TEST IDENTIFICATION TO...

TestSpecificationMinMaxASSAY (ANHYDROUS, SOLVENT-FREE BASIS)97.5101.50%RESIDUE ON IGNITION0.10%HEAVY METALS10 ug/gRELATED COMPOUNDSTO PASS TESTTO PASS TESTWATER DETERMINATION1.00%

TestSpecificationMinMaxMELTING POINT215??219??SOLUBILITYTO PASS TESTTO PASS TEST

TestSpecificationMinMaxPOTENCY750 ug/mg LOSS ON DRYING5.00%RESIDUE ON IGNITION3.00%AMPHOTERICIN A15%IDENTIFICATIONTO PASS TESTRETEST DATERESIDUAL SOLVENTS

Test Specification Min Max ASSAY (C[@28@]H[@37@]ClO[@7@] 97 102.00% SPECIFIC ROTATION, [a][@D@]25 +21??to +25??/td> +21??to +25??/td> LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 900 1050 ??/mg CRYSTALLINITY TO PASS TEST pH OF A 0.2% SOLUTION 3.5 6 WATER DETERMINATION 11.5 14.50% DIMETHYL ANILINE TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH 3.2 3.8 RELATED SUBSTANCES TO PASS TEST TO PASS TEST IMPURITY...

Test Specification Min Max ASSAY (C[@11@]H[@12@]Cl[@2@]N[@2@]O[@5@]) 555 - 595 ??/mg 555 - 595 ??/mg MELTING RANGE 87??- 95?? 87??- 95?? SPECIFIC ROTATION, [a] (C=5;ANHYD. ALCOHOL) +21??to +25??/td> +21??to +25??/td> CRYSTALLINITY...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO PASS TEST SULFATHIAZOLE AND OTHER PRIMARY AROMATIC...