Item

Specification

Description

Off-white to pale yellow crystalline powder

Clarity and color of solution

The solution is clear

≤0.20(430nm)

Identification

A

The IR absorption spectrum of a substance, corresponds to that obtained concomitantly for the corresponding USP Reference Standard

B

The retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.

C

It responds to the tests for Sodium 191.A dense precipitate is formed.

Specific rotation

+58°and~+64°

pH

4.5~6.5

Loss on drying

NMT3.0%

Particulate matter

≥10μm,Not exceed 6000

≥25μm,Not exceed 600

Chromatographic purity

Any individual impurity: not more than 1.0%

Total impurities: not more than 3.0%

Bacterial endotoxins

Not more than 0.20 USP Endotoxin Unit per mg

Sterility

Should be sterile

Assay

916μg/mg~964μg/mg