Characters

White or almost white crystalline granule and powder

White crystalline powder

Identification

The spectrum obtained with the substance to be examined corresponds with that obtained with reference standard

Conforms

Should meet the requirement under water

Conforms

Appearance of solution

≤reference suspension Ⅱ(1 mol/L hydrochloric acid)

Conforms

≤reference suspension Ⅱ(2 mol/L ammonia)

Conforms

PH

3.5~5.5

4.4

Specific optical rotation

+280~+305

296

Related substances

Any impurity≤1.0%

0.26%

Dimethylanilline

≤20ppm

Complies

Water

12.0%~15.0%

13.3%

Sulphated ash

≤0.5%

0.0007

Bulk density

0.45g/ml~0.65g/ml

0.57g/ml

Tapped density

≥0.65g/ml

0.76g/ml

Assay

96.0%~102.% C16H19N3O4S(calculated on the anhydrous basis)

99.7%

Conclusion: Complies with USP39