Description

White crystals or crystalline powder

conforms

Identification(IR)

concordant with the reference  spectrum

conforms

assay

98.5~101.5%

99.7%

PH

5.5~7.0

6.06

Specific rotationD25

+14.9°~+17.3°

+15.64°

Chloride(Cl)

≤0.05%

<0.05%

Sulfate(SO4)

≤0.03%

<0.03%

Iron(Fe)

≤30ppm

<30ppm

Heavy metals(Pb)

≤15ppm

<15ppm

Loss on drying

≤0.20%

0.10%

Residue on ignition

≤0.40%

0.03%

Chromatographic purity

conforms

conforms

Conclusion

Passed test according to the Standard of USP32.