Test items

Requirements

Results

Description

A White or off-white crystalline powder; odorless; tasted bitter.

Complies

Solubility

Slightly soluble in water, very slightly soluble in dehydrated alcohol, soluble in DMF and very soluble DMSO.

Complies

Identification

A. IR

A: Conform to reference standard

Conforms

B. Chemical Property

B: Dissolve 0.1g the sample with 10ml water, add 5ml dinitro-phenyl-hydrazine, should have marron precipitate.

Positive

C. HPLC

C: The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation

Conforms

Loss on drying

≤ 1.0%.

0.21%

Residue on ignition

≤ 0.1%.

0.07%

Heavy metals

≤ 0.002%.

Complies

Chloride

≤ 0.002%.

Complies

Impurities by HPLC

Any impurity(Max)

Total impurities

≤ 0.1%.

≤ 0.3%.

0.042%

0.08%

Residual solvents

Ethyl acetate

Alcohol

DMSO

≤ 0.5%.

≤ 0.5%.

≤ 0.5%.

Complies

Complies

Complies

Assay (HPLC)

98.5%~102.0%

99.80%