Items

Specifications

Results

Appearance

White or off white crystalline powder.odourless tasteless.lightly soluble in water,methanol solution,soluble in mixed solution of 15 volume water and 35 volume tetrahydrofuran,almost unsoluble in acetone.

Conform

Identification(1)

The retention time of the main peak of the supplier should be consistent with the retention time of the control peak of Doxazosin Mesylate

Conform

Identification(2)

The infrared absorption spectra of this product should be consistent with the control map(spectral set 733)

Conform

pH

2.5~4.5

3.8

Cl-

≤0.06%

Conform

Related substance

Each impurtity not more than 0.10%

Sum of impurtities not more than 0.3%

methanol≤0.3%

Ethyl acetate≤0.5%

0.042%

0.2%

ND

ND

Organic solvent residue

• butanol≤0.5%

Toluene≤0.089%

dichloromethane≤0.06%

ND

ND

ND

Loss on drying

Not more than 1.0%

0.16%

Methyl methanesulfonate

Not more than 1900ppm(0.19%)

ND

Residue on ignition

≤0.1%

0.06%

Heavy metals

Not more than 10ppm

Conform

含量（%）

Assay

Not less than 98.0%-102.0%

99.1%

Microbial limit

Should be meet the requirements

meet the requirements

conclusion

This product conforms with the standard of Chp2020