TestSpecificationMinMaxASSAY98%

TestSpecificationMinMaxPURITY (HPLC; Area %)85.00%WATER4.7- 5.2 %4.7- 5.2 %

TestSpecificationMinMaxPURITY (GC)95.00%MELTING POINT42.0 - 46.0�C42.0 - 46.0�C

TestSpecificationMinMaxPURITY (GC)98.00%MELTING POINT59.0 - 63.0�C59.0 - 63.0�C

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxPURITY (Argentmetric Titration)98.00%

TestSpecificationMinMaxPURITY (TLC)89.00%89.00%SPECIFIC ROTATION, [a][@D@]20-27.0� to -31.0-27.0� to -31.0

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�...

TestSpecificationMinMaxASSAY99%

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)98.00%

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 %

TestSpecificationMinMaxAPPEARANCE

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) 97 102.00% pH OF A 1 IN 100 SOLUTION 5.5 7.5 WATER DETERMINATION 11.60% CHLORIDE 0.05% SULFATE 0.05% ARSENIC 3 ppm REDUCING SUBSTANCES...

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...

TestSpecificationMinMaxABSORPTION MAX599 nm599 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...

TestSpecificationMinMaxASSAYAPPROX. 98 %APPROX. 98 %

TestSpecificationMinMaxASSAY (C[@5@]H[@11@]NO[@2@])98%98%

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...

TestSpecificationMinMaxASSAY99%99%

TestSpecificationMinMaxEXPIRATION DATE

TestSpecificationMinMaxACTIVITY150 U/g

TestSpecificationMinMaxASSAYAPPROX. 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...