Item

Specification  

Result

Description

White to off-white powder

White crystalline powder

Identification

HPLC retention time conforms with the reference conforms

HPLC retention time conforms with the reference conforms

Melting point (℃)

42~46℃

43~45℃

Specific optical rotation

-31.0~41.0°

-35.9°

Water content %(K&F)

≤0.5%

<0.1%

Residual solvents

ETOH:NMT 0.5%

ETOAc:NMT 0.5%

n-Heptane:NMT 0.5%

ETOH:Not detected

EtoAc:Not detected

n-Heptane: <0.1%

Residual on ignition

≤0.2%

<0.1%

Loss on drying

≤0.5%

0.39%

Heavy metals as Pb

≤20ppm

<20ppm

Assay by HPLC

≥98.0%

98.7%

purity

≥98.0%

98.8%

Residue on ignition

≤0.1%

0.06%

Max.individual impurity

≤0.5%

0.3%

Total impurities

≤2.0%

1.2%