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Powder: | Yes |
Customized: | Non-Customized |
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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: C23H23NO4
Molecular Weight: 377.433
DescriptionFluoxetine was shown to be effective for depression in six-week-long double-blind controlled trials, where it also alleviated anxiety and improved sleep. Fluoxetine was better than placebo for the prevention of depression recurrence when the patients, who originally responded to fluoxetine, were treated for a further 38 weeks. Efficacy of fluoxetine for geriatric, as well as pediatric, depression was also demonstrated in placebo-controlled trials.
Research suggests that a significant part of the resistance to the SSRIs paroxetine (Paxil) and citalopram(Celexa) can be explained by the genetic variation of Pgp transporter. Paroxetine and citalopram, which are Pgp substrates, are actively transported from the brain by this protein. Fluoxetine is not a substrate of Pgp, and thus a switch from paroxetine or citalopram to fluoxetine may be beneficial to the nonresponders
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 |