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CAS No: | 120011-70-3 | Molecular Formula: | C24H30ClNO3 |
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Molecular Weight: | 415.95 | EINECS No: | 620-543-2 |
Melting Point: | 220-222 ° C | Boiling Point: | 527.9 C At 760 MmHg |
Flash: | 273.1ºC | Steam Pressure: | 3.11e-11mmhg At 25°C |
Storage Conditions: | - 20 ° C Freezer | Appearance: | White To Off-white Crystalline Solid |
High Light: | active pharma ingredients,api pharmaceuticals |
PRODUCT NAME |
DONEPEZIL HCL |
BATCH NO |
20191028 |
TEST DATE |
2019.10.28 |
BATCH SIZE |
500KG |
MFG DATE |
2019.10.28 |
EXP. DATE |
2021.10 |
TEST ITEM |
SPECIFICATION |
RESULT |
Appearance |
Off white to white crystalline powder |
Complies |
Solubility |
Freely soluble in chloroform, soluble in water and Acetic acid, slightly soluble in Acetonitrile and ethanol, insoluble in Ethylacetoacetate and n-hexane. |
Complies |
Identification |
(1)By IR absorption ,To match with working standard. |
Complies |
(2) The retention time of the major peak of the sample should accord with that of the working standard. |
Complies |
|
(3) Test for chlorides. Reponds to the test for Chlorides. |
Complies |
|
Water |
≤0.4% |
0.31% |
Residue on ignition |
≤0.1% |
0.02% |
Related substance |
Desbenzyl donepezla≤0.15% Donepezil pyridine analogb≤0.15% Donepezilzilbenzyl bromidec≤0.15% Dehydrodeoxy donepezild≤0.15% Deoxy donepezile≤0.15% Any Unkonwn single impurity≤0.10% Total ≤0.5% |
Not detected Not detected 0.02% Not detected Not detected 0.05% 0.18% |
Heavy metal |
≤20ppm |
≤20ppm |
Residual Solvents |
Methanol≤0.3% Ethanol≤0.5% Ethyl acetate≤0.5% Toluene≤0.089% Acetic acid≤0.5% |
Not detected Not detected Not detected Not detected Not detected |
Assay |
On dried base, C24H29NO3·HCl should be 98.0% to 102.0%. |
99.52% |
Conclusion:Conforms to USP36. |
Structure:
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