Test Specification Min Max PURITY (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 ASSAY 99%

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...

Test Specification Min Max PURITY (GC) 80.00% REFRACTIVE INDEX @ 20�C 1.4980 - 1.5020 1.4980 - 1.5020

Test Specification Min Max PURITY (GC) 98.00%

Test Specification Min Max PURITY (GC) 99.00% SPECIFIC GRAVITY @ 20[d/20[dC 0.8670 - 0.8690 0.8670 - 0.8690 REFRACTIVE INDEX @ 20�C 1.4030 - 1.4050 1.4030 - 1.4050

Test Specification Min Max PURITY (NEUTRALIZATION TITRATION; ANHYDROUS BASIS) 98.00% WATER 6.5 - 7.2 % 6.5 - 7.2 %

Test Specification Min Max APPEARANCE

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 ABSORPTION MAX 599 nm 599 nm

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...

Test Specification Min Max ASSAY APPROX. 98 % APPROX. 98 %

Test Specification Min Max ASSAY (C[@5@]H[@11@]NO[@2@]) 98% 98%

Test Specification Min Max APPEARANCE WHITE POWDER WHITE POWDER SOLUBILITY (2% DIMETHYLFORMAMIDE) CLEAR AND COLORL CLEAR AND COLORL PURITY (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 99% 99%

Test Specification Min Max EXPIRATION DATE

Test Specification Min Max ACTIVITY 150 U/g

Test Specification Min Max ASSAY APPROX. 98 % APPROX. 98 %

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 APPEARANCE EXPIRATION DATE

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...

Test Specification Min Max APPEARANCE