Test Specification Min Max ASSAY (ANHYDROUS BASIS) 600 ug/g 600 ug/g CRYSTALLINITY TO PASS TEST TO PASS TEST WATER 4.00% FREE ERYTHROMYCIN 3.00% IDENTIFICATION TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 103.0% 97.0 - 103.0% SPECIFIC ROTATION [a][@D@] +51??to +56??/td> +51??to +56??/td> LOSS ON DRYING 2.00% RELATED ALKALOIDS TO PASS TEST IDENTIFICATION...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a]D25 +39.5 to +43.0??/td> +39.5 to +43.0??/td> pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE...
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +82??to +88??/td> +82??to +88??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.40% RESIDUE ON IGNITION 0.10% ELEMENTAL...
Test Specification Min Max ASSAY 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION...
Test Specification Min Max ASSAY (DRIED BASIS) 92.0 - 103.0% 92.0 - 103.0% LOSS ON DRYING 1.50% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0 - 102.0 % 98.0 - 102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER 0.50% RESIDUE ON IGNITION 0.10% HEAVY...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +110??to +116??/td> +110??to +116??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES...
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 69??- 72?? 69??- 72?? RESIDUE ON IGNITION 0.10% SELENIUM 30 ppm IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE...
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) 96 102.00% LOSS ON DRYING 12.00% RELATED COMPOUNDS TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED LEAD...
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 (DRIED BASIS) 98.5 100.50% LOSS ON DRYING 33 36.50% SODIUM (Na) 0.02% POTASSIUM (K) 0.01% CALCIUM (Ca) 0.01% IRON (Fe) 0.00% NICKEL (Ni) 0.01% ELEMENTAL...
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) 98.0 - 101.5% 98.0 - 101.5% MELTING RANGE 195??- 198?? 195??- 198?? LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% OTHER ALKYLATED PHENOTHIAZINES...
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 ASSAY (ANHYDROUS BASIS) 99.5 100.50% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST COLOR OF SOLUTION TO PASS TEST TO PASS TEST WATER DETERMINATION 7.5...
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 (CaSO[@4@]) 98 101.00% LOSS ON DRYING 19 23.00% IRON (Fe) 100 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED HALAL EXPIRATION...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% CALCIUM CONTENT (Ca; DRIED BASIS) 8.2 8.60% OPTICAL ROTATION +25.0??o+27.5??/td> +25.0??o+27.5??/td> LOSS ON DRYING 5.00% ALKALINITY TO PASS TEST ELEMENTAL IMPURITIES:...
Test Specification Min Max ASSAY (CaO) 95.00% LOSS ON IGNITION 10.00% INSOLUBLE SUBSTANCES 1.00% CARBONATE (CO[@3@]) TO PASS TEST TO PASS TEST MAGNESIUM AND ALKALI SALTS TO PASS TEST TO...
Test Specification Min Max ASSAY 95 100.50% ACID-INSOLUBLE SUBSTANCES 0.50% CARBONATE TO PASS TEST TO PASS TEST HEAVY METALS (JP) 20 ppm ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (ZnO; AFTER IGNITION) 98 100.50% MICROBIAL LIMITS TO PASS TEST LOSS ON IGNITION 2.00% ACID-INSOLUBLE SUBSTANCES 2.00% ALKALINE SUBSTANCES TO PASS TEST ARSENIC (As) 8...
Test Specification Min Max CARBOXYLIC ACID GROUPS (DRIED BASIS) 56 68.00% VISCOSITY OF A NEUTRALIZED[n0.5 % AQUEOUS DISPERSION 30,500-39,400mPa 30,500-39,400mPa LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES As Reported BENZENE 0.50%...
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 BASIS) 98.5 101.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES: ARSENIC (As) AS REPORTED AS REPORTED CADMIUM...