ITEMS

SPECIFICATIONS

TEST RESULT

CONCLUSION

Character

White to Gray-yellow powder

Gray-yellow powder

Conform

Identification

The retention time for the main peaks of sample should be thesame as the retention time for reference standard

Conform

Conform

Water Content

Not more than 3.0% 

1.1%

Conform

Clarity of solution

Clear or no more turbid than reference suspension 1

< 1

Conform

Degree of coloration

Should be less colored than the yellow No.9 standardsolution

< 7

Conform

pH

5.5~7.5

5.7

Conform

Residual solvent

Content of methanol, acetone,  dichloromethane andisopropyl ether not more than 2.0%

0.7%

Conform

Bacterial Endotoxins

Not more than 0.2EU/mg

Conform

Conform

Particulate matters

≥10µm, no more than 5000 grain/vial

≥25µm, no more than 500 grain/vial

360

 17

Conform

Sterility Test

It should conform to the standard

Conform

Conform

Visible particles

It should conform to the standard

Conform

Conform

Assay

(anhydrous basis)

Content ofC19H16N5O7S3not less than 98.0%

101.9%

Conform