Test Specification Min Max ASSAY 98 100.50% SPECIFIC GRAVITY @ 25[dC 1.013 1.016 DISTILLING RANGE (95 %) 167?? 173?? RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...

Test Specification Min Max SPECIFIC GRAVITY @ 25[dC 0.818 0.88 VISCOSITY @40.0 C 3 34.4 mm??s ACIDITY TO PASS TEST TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +22.4 to+24.7??/td> +22.4 to+24.7??/td> pH (1 IN 100) 5.6 6.1 LOSS ON DRYING 0.30% RELATED COMPOUNDS TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% RELATED COMPOUNDS TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 3 9.00% CHLORIDE 0.05% SULFATE 0.20% LEAD 10 ppm HEAVY METALS 20 ppm REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% 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 MELTING RANGE 38?? 44?? IODINE VALUE 18 36 ACID VALUE TO PASS TEST TO PASS TEST ALKALINITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.25%...

Test Specification Min Max CLARITY AND COLOR OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a][@D@] +54.4 to+55.9 +54.4 to+55.9 ACIDITY / ALKALINITY TO PASS TEST WATER DETERMINATION 4.5 5.50% MICROBIAL...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ETHYNYL GROUP 7.81 8.18% MELTING RANGE (WITHIN 4??) 232?? 239?? SPECIFIC ROTATION, [a][@D@]25 -30??to -35??/td> -30??to -35??/td> RESIDUE ON IGNITION 0.30%...

Test Specification Min Max ASSAY 790 ug/mg 790 ug/mg SPECIFIC ROTATION [a][@D@] +135 to +150 +135 to +150 CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF A 1 IN...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] +20.4 to +21.4??/td> +20.4 to +21.4??/td> CHLORIDE CONTENT 19 19.60% RELATED COMPOUNDS TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % SPECIFIC ROTATION [a][@D@] +8.4 to +9.9 +8.4 to +9.9 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON...

Test Specification Min Max ASSAY (C[@21@]H[@31@]N[@3@]O[@5@]; ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION -115.3 to -122.5 -115.3 to -122.5 WATER DETERMINATION 8 9.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@]20 +20.4 to +21.4??/td> +20.4 to +21.4??/td> CHLORIDE CONTENT 19 19.60% RELATED COMPOUNDS TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92 97.0?? SPECIFIC ROTATION [a][@D@] +1 to -1??/td> +1 to -1??/td> LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...

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[@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...

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%...

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 (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...

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...