Appearance

White to almost white powder

Conform

Identification

TLC Identification

The test solution is similar in position, colour to the principal spot in the chromatogram obtained with reference solution.

Conform

HPLC Identification

The retention time of major peak obtained from the sample solution should be consistent with that obtained from standard solution.

Conform

Sulfate Ident.

Present the identification of sulfate.

Conform

PH

6.0-8.0

7.5

Water

≤2.0%

1.3%

Heavy metals

≤30ppm

Conform

Residue on ignition

≤1.0%

0.13%

Chromatographic purity

≤1.0%

Conform

Bacterial endotoxins

≤2.0EU/mg

Conform

Residual Solvents(ethanol)

≤5000ppm

27ppm

Assay(on the anhydrous basis)

634-739 μg/mg

710μg/mg