Fluoxetine Hydrochloride 59333-67-4 Sarafem
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Products Name: Fluoxetine hydrochloride
Synonyms : Methyl[3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl]amine hydrochloride; N-Methyl-gama-[4-(trifluoromethyl)
CAS No: 59333-67-4;56296-78-7
EINECS No: 260-101-2
Molecular Formula: C17H19ClF3NO
Molecular Weight: 345.787
Appearance |
White crystal |
White crystal |
Identification A:Infrared absorption B:Retention of time |
A: Positive B: Positive |
A: Complies B: Complies |
Assay |
98.0~101.5% |
100.20% |
Optical rotation |
-0.05~+0.05 |
+0.01 |
Total impurity |
≤0.5% |
Complies% |
3-methylaminol-l-phenylpropan-l-ol |
≤0.25% |
0.05% |
N-methyl-3-phenylpropyl-l-amine |
≤0.25% |
0.05% |
N-methyl-3-phenyl-3-(trifluoromet hylphenoxy) propyl-l-amine |
≤0.15% |
0.03% |
Other impurity |
≤0.10% |
Complies |
Organic volatile impurity |
Complies |
Complies |
Sulphated ash |
≤0.1% |
0.02% |
Water |
≤0.5% |
0.20% |
pH |
4.5~6.5 |
5.70 |
Heavy metals |
≤10ppm |
Complies |
Solubility |
Colorless clear |
Colorless clear |
TVC |
≤10 cfn/g |
Complies |
Mould and yeast |
≤10 cfn/g |
Complies |
Conclusion: comply with the USP30/BP2002 |
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