Test Specification Min Max ASSAY 98.0-101.0 % 98.0-101.0 % MELTING RANGE 106 - 109 C 106 - 109 C SPECIFIC ROTATION, [a][@D@](C = 1) -20 to-23 -20 to-23 LOSS ON...

Test Specification Min Max VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 2663 4970mPa?? ASSAY (METHOXY GROUPS) 19 24.00% ASSAY (HYDROXYPROPOXY GROUPS) 4 12.00% pH 5 8 LOSS ON...

Test Specification Min Max VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 40 60 mPa?? ASSAY (METHOXY GROUPS) 28 30.00% ASSAY (HYDROXYPROPOXY GROUPS) 7 12.00% pH 5 8 LOSS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 120??- 124?? 120??- 124?? SPECIFIC ROTATION +58??to +64??/td> +58??to +64??/td> WATER DETERMINATION 0.10% FREE n-CAPROIC ACID 0.58% ORDINARY IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 95 102.00% pH (2 in 100 SOLUTION) 8 10 WATER DETERMINATION 14 18.00% RELATED COMPOUNDS TO PASS TEST ACETONE 0.50% ELEMENTAL IMPURITIES:...

Test Specification Min Max ACTIVITY 300 IU/mg 300 IU/mg APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH (0.3% SOLUTION) 4.5 - 7.5 4.5 - 7.5 LOSS ON DRYING...

Test Specification Min Max APPEARANCE White or almost White or almost ASSAY (DRIED SUBSTANCE) 99.0 - 101.0 % 99.0 - 101.0 % RELATED SUBSTANCES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE AFTER IGNITION 0.50% CHLORIDE (Cl) 0.02%...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] 126?? 138??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 3.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.40% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO...

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) 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...