Test Specification Min Max ALCOHOL DETERMINATION 44 50.00% IODINE 1.8 2.2 g/100ml SODIUM IODIDE (NaI) 2.1 2.6 g/100ml ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST...
Test Specification Min Max ASSAY [(C[@11@]H[@17@]NO[@3@])[@2@][-H[@2@]SO[@4@]] 97.0- 103.0 % 97.0- 103.0 % WATER 7.00% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.14% ISOPROTERENONE TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (C[@19@]H[@24@]N[@2@][-HCl; DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (C[@16@]H[@16@]CIN[@3@]O[@3@]S; DRIED BASIS) 98 101.00% LOSS ON DRYING @ 105 C 3.00% RESIDUE ON IGNITION 0.10% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST IDENTIFICATION...
TestSpecificationMinMaxASSAY98.50%WATER0.50%TITRATABLE ACID0.002 meq/RESIDUE AFTER EVAPORATION0.00%ACIDS AND ESTERS (as AMYL ACETATE)0.20%CARBONYL (as HCHO)0.10%
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES TO PASS TEST IBUPROFEN RELATED COMPOUND C 0.10%...
TestSpecificationMinMaxMELTING RANGE232 - 234 C (dec232 - 234 C (dec
Test Specification Min Max ASSAY (HYDROXYPROPOXY GROUPS) 53.4 80.50% APPARENT VISCOSITY OF A 2% AQUEOUS SOLN. @25?? As reported As reported pH OF A 1% SOLUTION 5 8 LOSS ON...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% MELTING RANGE 172?? 174?? RESIDUE ON IGNITION 0.50% WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION (A) TO PASS...
Test Specification Min Max VISCOSITY OF A 5% AQUEOUS SOLUTION 50 150 cPs pH OF A 1 % SOLUTION @ 25[dC 6 8.5 LOSS ON DRYING 10.00% LEAD (Pb) 10...
Test Specification Min Max ASSAY (H[@2@]O[@2@]) 2.5 3.50% ACIDITY TO PASS TEST TO PASS TEST NONVOLATILE RESIDUE (w/v) 0.15% BARIUM TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: TIN (Sn)...
TestSpecificationMinMaxASSAY (I/Cl RATIO OF SOLUTION)1.10+/-0.11.10+/-0.1INSOLUBLE MATTER0.01%
Test Specification Min Max ASSAY (HIO[@3@]) 99.50% INSOLUBLE MATTER 0.01% RESIDUE AFTER IGNITION 0.02% CHLORIDE AND BROMIDE (as Cl) 0.02% IODIDE (I) TO PASS TEST TO PASS TEST NITROGEN COMPOUNDS...
TestSpecificationMinMaxAPPEARANCEEXPIRATION DATE
TestSpecificationMinMaxASSAY0.09500 -0.105000.09500 -0.10500TRACEABLE TO NISTAPPEARANCEEXPIRATION DATE
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% SPECIFIC ROTATION [a][@D@] -24??to -29??/td> -24??to -29??/td> WATER DETERMINATION 2.5 5.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5-100.5 % 98.5-100.5 % MELTING POINT 149 C SPECIFIC ROTATION [a][@D@] -24 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% OTHER ALKALOIDS TO...
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...
TestSpecificationMinMaxASSAY (by TITRATION)98%98%
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH (1 in 50) 3.5 4.2 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED HYDRAZINE 0.00% ORGANIC...
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...