Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.10% HEAVY METALS 10 PPM CHLORIDE TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0-100.5 % 98.0-100.5 % MELTING RANGE 227 - 234 C 227 - 234 C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% IDENTIFICATION...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 102.0 % 99.0 - 102.0 % MELTING RANGE 169 - 174 C 169 - 174 C pH OF A 1 IN...

Test Specification Min Max ASSAY (DRIED BASIS) 95 101.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% RELATED GLYCOSIDES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO...

Test Specification Min Max POTENCY (C[@22@]H[@24@][N[@2@]O[@8@]) 880 980 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF SOLUTION 5 6.5 WATER DETERMINATION 3.6 4.60% ORGANIC IMPURITIES TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT FREE BASIS) 94 101.00% SPECIFIC ROTATION [a][@D@] -240??to -250??/td> -240??to -250??/td> CHROMATOGRAPHIC PURITY TO PASS TEST WATER DETERMINATION 2.00% COLCHICEINE TO PASS TEST...

Test Specification Min Max ASSAY 98.50% WATER DETERMINATION 0.50% TETRACHLOROETHYLENE 0.40% RESIDUE ON IGNITION 0.10% IRON 0.01% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: COPPER (Cu) AS...

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...

Test Specification Min Max ASSAY (CrCl[@3@][-6H[@2@]O) 98 101.00% INSOLUBLE MATTER 0.01% SUBSTANCES NOT Pptd BY NH[@4@]OH (as SO[@4@]) 0.20% SULFATE 0.01% IRON (Fe) 0.01% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...

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...