TestSpecificationMinMaxPURITY (Argentmetric Titration)99.00%
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 41 44�C SPECIFIC ROTATION [a][@D@]25 -45� to -51� -45� to -51� NONVOLATILE RESIDUE 0.05% RELATED COMPOUNDS TO PASS TEST ELEMENTAL IMPURITIES...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % MELTING RANGE 148� - 152�C 148� - 152�C SPECIFIC ROTATION, [a][@D@]20 -1� to +1� -1�...
Test Specification Min Max APPEARANCE Clear yellow to Clear yellow to IR SPECTRUM To pass test To pass test PURITY BY GAS CHROMATOGRAPHY 99% SPECIFIC ROTATION @ 25 C -130...
TestSpecificationMinMaxPURITY (GC)80.00%REFRACTIVE INDEX @ 20�C1.4980 - 1.50201.4980 - 1.5020
TestSpecificationMinMaxPURITY (GC)99.00%SPECIFIC GRAVITY @ 20[d/20[dC0.8670 - 0.86900.8670 - 0.8690REFRACTIVE INDEX @ 20�C1.4030 - 1.40501.4030 - 1.4050
TestSpecificationMinMaxPURITY (NEUTRALIZATION TITRATION; ANHYDROUS BASIS)98.00%WATER6.5-7.2 %6.5-7.2 %
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED REDUCING SUGARS 0.20% OTHER POLYOLS 2.00% IDENTIFICATION TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.0 - 102.0 % 97.0 - 102.0 % CADMIUM (Cd) 2 mg/kg CHLORIDE (Cl) 0.05% LEAD (Pb) 2 mg/kg REDUCING SUBSTANCES 1.00% SULFATE...
Test Specification Min Max ASSAY 96 102.00% ACIDITY TO PASS TEST ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED LEAD (Pb) AS REPORTED AS REPORTED ARSENIC (As) AS REPORTED AS...
Test Specification Min Max ASSAY 98.50% SPECIFIC ROTATION [a][@D@] +27.2� to +29.0 +27.2� to +29.0 LEAD (Pb) 10 ppm HEAVY METALS 20 ppm LOSS ON DRYING 0.30% RESIDUE ON IGNITION...
TestSpecificationMinMaxAPPEARANCEWHITE POWDERWHITE POWDERSOLUBILITY (2% DIMETHYLFORMAMIDE)CLEAR AND COLORLCLEAR AND COLORLPURITY (ENZYMATIC)98%RETEST DATE
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 +18.2 to+19.4� +18.2 to+19.4� COLOR OF A 10% SOLUTION TO PASS TEST LOSS ON DRYING 0.10% ORGANIC IMPURITIES...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.20% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% MELTING RANGE 200 205�C SPECIFIC ROTATION [a][@D@] +57� to +62� +57� to +62� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % SPECIFIC ROTATION [a][@D@] +26.6 to+28.8 +26.6 to+28.8 pH OF A 5% SOLUTION 5.5 7 RELATED...
Test Specification Min Max ASSAY 98.50% SPECIFIC ROTATION, [a][@D@]20 -26.5� to -29.0 -26.5� to -29.0 LEAD (Pb) 10 ppm RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.20% HEAVY METALS 0.00%...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 2% SOLUTION @ 25�C 6 7.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.06% RELATED...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 2.7 3.4 WATER DETERMINATION 5.00% RELATED COMPOUNDS 1.00% RESIDUE ON IGNITION 0.20% ABSORBANCE...
Test Specification Min Max ASSAY 97 102.00% LOSS ON DRYING @ 105 C 0.50% ORGANIC IMPURITIES: . . THEOPHYLLINE RELATED COMPOUND C 0.10% THEOPHYLLINE RELATED COMPOUND B 0.10% THEOPHYLLINE RELATED...