Test Items

Specifications

Result

Appearance

White or almost white powder

Conforms

Solubility

Practically insoluble in water, soluble in ethanol(96 per cent).

Conforms

Identification

A. Ultraviolet and visible absorption spectrophotometry

Conforms

B. Infrared absorption spectrophotometry

Conforms

C. Thin-layer chromatography

Conforms

Optical rotation

-0.02°~ +0.02°

0°

Water (EP 2.5.12)

≤3.0%

2.2%

Sulphated ash (EP 2.4.14)

≤0.1%

0.03%

Heavy metals (EP 2.4.8)

≤10ppm

<10ppm

Related compounds

Impurity B≤0.3%

0.1%

Unspecified impurity≤0.10%

Conforms

Total impurities≤0.5%

0.1%

Impurity A

≤5ppm

Conforms

Assay

98.0 per cent to 102.0 per cent (anhydrous substance).

99.8%

Storage:

Keep in well-closed container, protected from light.