Items

Standards

Results

Appearance

White or slightly yellow crystal powder

Complies

Solubility

Soluble in DMF and insoluble in ether

Complies

NMR and MS

Should comply

Complies

Identification

IR and HPLC

Complies

Specific rotation

[α]20/D, (c=0.4, in water)

+218° ~ +222°

220°

Loss weight on dryness

Max. 1%

0.5%

Any impurity

Max. 0.5%

Complies

Residue on ignition

Max.1%

0.2%

Heavy metals

Max.20 ppm

Complies

TLC

Should be one spot

one spot

Purity

Min.98%

99.2%

Assay by HPLC

98% ~ 102%

99.4%