59333-67-4 Fluoxetine hydrochloride Fluoxetine HCL
Products Name: Fluoxetine hydrochloride
CAS No: 59333-67-4;56296-78-7
EINECS No: 260-101-2
Molecular Formula: C23H23NO4
Molecular Weight: 377.433
ITEMS |
STANDARDS |
RESULTS |
|
Appearance |
White crystal powder |
White crystal powder |
|
Assay, % |
98.0~102 |
99.65 |
|
Identification |
Ir and chloride |
Complies |
|
Melting Point, °C |
155~159 |
158.1-158.9 |
|
Optical rotation, ° |
-0.05~+0.05 |
0.00 |
|
Impurity |
Total impurity, % |
≤0.5 |
0.13 |
3-Methylamino-1-phenylpropan-1-ol, % |
≤0.25 |
0.01 |
|
N-Methyl-3-phenylpropan-1-amine, % |
≤0.25 |
0.02 |
|
N-Methyl-3-phenyl-3-[3-(trifluoromet hyl)phenoxy]propan-1-amine, % |
≤0.15 |
0.05 |
|
Other single impurity, % |
≤0.10 |
complies |
|
Residue on ignition, % |
≤0.1 |
0.04 |
|
Water, % |
≤0.5 |
0.02 |
|
pH |
4.5~6.5 |
6.26 |
|
Heavy metals, ppm |
≤20 |
Complies |
|
Solution in methanol |
Clear and colorless |
Clear and colorless |
|
Conclusion:Comply with USP 33/EP7 |
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