| Function: | Anti Hypertension, Prostate Disease Drugs |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier | Items | Standard | Results | |
| Appearance | White or off white crystalline powder.odourless tasteless. lightly soluble in water,methanol soulution,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 doxazsin 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 | 3.9 | |
| Cl- | ≤0.06% | Conform | |
| Related substance | Each impurity not more than 0.10% Sum of impurities not more than 0.3% Methanol≤0.3% Ethyl acetate≤0.5% |
0.034% 0.07%
N.D
N.D |
|
| Organic solvent residue |
N-butanol≤0.5%
Toluene≤0.089%Dichloromethane≤0.06% |
N.D N.D N.D |
|
| Heavy metals | Not more than 10ppm | Conform | |
| Loss on drying | Not more than 1.0% | 0.47% | |
| Methyl methanesulfonate | Not more than 1900ppm(0.19%) | N.D | |
| Residue on ignition | ≤0.1% | 0.04% | |
| Assay | Not less than 98.0%~102.0%(dried substance) | 99.7% | |
| Microbial limit | Should be meet the requirements | Meet the requirements | |
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