Item

Acceptance criteria

Result

Character

Almost-white or light yellow unfixed powder, smell-less, hygroscopic freely.

white unfixed powder, smell-less, hygroscopic freely.

Solubility

Soluble in water very freely, hardly soluble in ethanol or chloroform or ethyl ether.

Conforms

Specific optical rotation

+10°－+16°

+12.0°

Identification

(1)The product appears flame reaction of sodium salt.

(2)UV:Max absorption at 225nm wavelength.

(3)IR:Meet the requirements.

Conform

Conform

Meet the requirements.

PH

6.5－8.5

7.2

Clarity and color of solution

Meet the requirements.

Conforms

Related substance

Max single impurity≤0.1%

0.036%

Total impurity≤0.5%

0.17%

D isomer

≤0.3%

Not Detected

Heavy Metal

<20ppm

Conforms

Water

7.2%－10.2%

8.8%

Chloride

≤0.02%

Conforms

Ethanol

≤5000ppm

1687ppm

Dichloromethane

≤600ppm

Not Detected

N,N-Dimethylformamide

≤880ppm

Not Detected

Purity

≥99.5%

99.83%

Assay

Not less than 98.50%, calculated on the anhydrous basis.

99.10%