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PRODUCT:DoxazosinMesylate QUANTITY: 50g BATCH NO.：20220901
SPECIFICATION: 50g/袋 TEST DATE：2022.09.14
MANUFACTURER DATE:2022.09.10 REPORT DATE:2022.09.19
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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 |
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 |
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