ITEMS

STANDARD

RESULTS

Characteristics

White or almost white crystalline powder

Almost white crystalline powder

Melting point

152~156

155.0~155.5

Specific optical rotation

-16°-19°

-17.4°

Identification 

The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay

Conforms

UV absorption Max. at 266 nm

Conforms

IR spectra is consistent with CRS

Conforms

PH

4.5~6.5

5.2

Chlorides

≤0.02%

0.02%

Fluorides

≥4.8%

4.8%

Related substances

Individual impurity ≤0.5%

Total impurities ≤2.0%

0.5%

0.9%

Residue on ignition

≤0.1%

0.07%

Water

≤0.5%

0.06%

Heavy metals

≤20ppm