Item

Specifications

Result

Description

White or almost white to slight yellow powder

Almost white powder

Special optical rotation

-55°～-62°

-57°

Absorbance

305～335

306

Identification

Conform

Conform

pH

5.5～7.5

6.7

Clarity of solution

Not more intense than reference suspension 1#

0.5

Color of solution                       

Not more intensely colored than 9#

5

Water

Not more than 4.0%

2.4%

Heavy metals                              

Not more than 0.0020%

＜0.0020%

Related substances

Individual impurity     NTM1.0%

Total impurity         NTM 1.5%

0.1%

0.3%

Sterility

Conform

Conform

Pyrogen

Conform

Conform

Assay(calculated as the anhydrous basis)

Contain C₂₀H₂₀N₆O₇S₄

not less than86.0%

91.4%