Items

Specification

Appearance

A white to off white powder

Identification

A. Meets the requirement

B.IR:similar to reference substance

Loss on drying

≤0.5%

Specific rotation

+ 10.0°~ +13.0°

Purity by HPLC R-isomer

≤0.15%

Residue on ignition

≤0.1%

Related substances

Any single impurity≤0.1%

Total impurity≤0.8%

Residual solvents

Isopropyl alcohol≤5000 ppm

Ethyl Acetate≤5000 ppm

Heavy metals

≤10ppm

Chlorides

≤ 0.05%

Assay

98.0% ~ 102.0%

Particle size

50μm≤ d(4.3)≤ 150μm

D(0.9)≤ 350μm