Duloxetine Hydrochloride NEW

136434-34-9

Characteristics

White or almost white crystalline powder,

Slightly soluble in water, freely soluble in formic acid,slightly soluble in anhydrous ethanol.

Melting point

about 230°C

Identification

1) should conformed

2) specific rotation: -17.5° to -20.5°

3) examine by infrared absorption spectrophotometry,compare the spectrum obtained with reference spectrum:should meet the requirements

4) should conformed

Related substances

Method A (EP method):

Largest single impurity should ≤0.1%

Method B(EP method):

Largest single impurity should≤0.1%

Total impurities should ≤0.2%

Enantiomeric purity

≤0.1%

Heavy metals

≤20ppm

Loss on drying

≤0.5%

Sulphated ash

≤0.1%

Assay

98.5% ~ 101.0%