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盐酸氟西汀BP2009质量标准
Browse: British Pharmacopoeia 2009
British Pharmacopoeia Volume I II
Monographs: Medicinal and Pharmaceutical Substances
Fluoxetine Hydrochloride
Fluoxetine Hydrochloride
General Notices
(Ph Eur monograph 1104)
C H F NO,HCl345.859333-67-4
17 18 3
Action and use
Selective serotonin reuptake inhibitor; antidepressant.
Preparations
Fluoxetine Capsules
Fluoxetine Oral Solution
Ph Eur
DEFINITION
(3RS)-N-Methyl-3-phenyl-3-[4-trifluoromethyl)phenoxy]propan-1-amine hydrochloride.
Content
98.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance
White or almost white, crystalline powder.
Solubility
Sparingly soluble in water, freely soluble in methanol, sparingly soluble in methylene chloride.
IDENTIFICATION
A. Infrared absorption spectrophotometer (2.2.24).
PreparationDiscs.
©Crown Copyright 2006 1
Comparisonfluoxetine hydrochloride CRS .
B. It gives reaction (a) of chlorides (2.3.1).
TESTS
Solution S
Dissolve 2.0 g in a mixture of 15 volumes of water R and 85 volumes of methanol R, then
dilute to 100 ml with the same mixture of solvents.
Appearance of solution
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).
pH (2.2.3)
4.5 to 6.5.
Dissolve 0.20 g in carbon dioxide-free water R and dilute to 20 ml with the same solvent.
Optical rotation (2.2.7)
- 0.05 ° to + 0.05 °, determined on solution S.
Related substances
Liquid chromatography (2.2.29).
Test solution (a)Dissolve 55.0 mg of the substance to be examined in the mobile phase and
dilute to 10.0 ml with the mobile phase.
Test solution (b)Dilute 2.0 ml of test solution (a) to 10.0 ml with the mobile phase.
Reference solutionDissolve 22.0 mg of fluoxetine hydrochloride CRS in 10.0 ml of 0.5 M
sulphuric acid . Heat at about 85 °C for 3 h. Allow to cool. The resulting solution contains
considerable quan
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