Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST WATER DETERMINATION 0.25% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST EXPIRATION DATE...

Test Specification Min Max CONTENT OF GALACTOMANNAN 66.00% 66.00% RATIO OF CONSTITUTING MANNOSE AND GALACTOSE 1.4 2.2 LOSS ON DRYING 15.00% TOTAL ASH 1.50% ACID-INSOLUBLE MATTER 7.00% ARSENIC 3 ??/g...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ERYTHRO ISOMER 0.40% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 900 ug/mg 900 ug/mg MELTING POINT (DRY) 229 C 229 C CRYSTALLINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 3.00% RESIDUE...

Test Specification Min Max ASSAY (Fe) 20 22 g/100 NITRATE (NO[@3@]) TO PASS TEST TO PASS TEST FERROUS SALTS TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...

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) 97 103.00% SPECIFIC ROTATION +81??to +89??/td> +81??to +89??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 103.0 % 97.0 - 103.0 % LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.25% IDENTIFICATION TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST MELTING RANGE 180?? 186?? SPECIFIC ROTATION [a][@D@] -28.0??to-29.5 -28.0??to-29.5 LOSS ON DRYING 1.00% IDENTIFICATION TO...

Test Specification Min Max ASSAY 98 102.00% COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST RESIDUE ON IGNITION 0.10% RELATED SUBSTANCES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +98??to +108??/td> +98??to +108??/td> LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.5 100.50% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED MALEIC ACID 0.10% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE...

Test Specification Min Max ASSAY (C[@18@]H[@22@]O[@2@]; DRIED BASIS) 97 103.00% CLARITY OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +158??to +165??/td> +158??to +165??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% MELTING RANGE 147 152?? LOSS ON DRYING 0.50% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS TEST NOREPINEPHRINE BITARTRATE 4.00% ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC ROTATION [a]D25 +158??to +165??/td> +158??to +165??/td> LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +54??to +62??/td> +54??to +62??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (as ETHYL (Z)-9-OCTADECENOATE) TO PASS TEST TO PASS TEST PRESENCE OF ESTER TO PASS TEST TO PASS TEST IODINE VALUE 75 85 PEROXIDE VALUE 10...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% SPECIFIC ROTATION -1??to +1??/td> -1??to +1??/td> WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ADRENALONE TO PASS TEST NOREPINEPHRINE 4.00% ELEMENTAL IMPURITIES:...

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) 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...