FLUPHENAZINEDECANATE
fluphenazine decanoate
CAS: 5002-47-1
Molecular Formula: C32H44F3N3O2S
FLUPHENAZINEDECANATE - Names and Identifiers
FLUPHENAZINEDECANATE - Physico-chemical Properties
| Molecular Formula | C32H44F3N3O2S |
| Molar Mass | 591.77 |
| Density | 1.149±0.06 g/cm3(Predicted) |
| Melting Point | 30-32° |
| Boling Point | 658.1±55.0 °C(Predicted) |
| Flash Point | 351.8°C |
| Solubility | Practically insoluble in water, very soluble in ethanol and in methylene chloride, freely soluble in methanol. |
| Vapor Presure | 3.4E-17mmHg at 25°C |
| Appearance | neat |
| pKa | 7.32±0.10(Predicted) |
| Storage Condition | -20℃ |
| Refractive Index | 1.537 |
| Use | For content determination |
FLUPHENAZINEDECANATE - Risk and Safety
| UN IDs | 3249 |
| RTECS | HE0525000 |
| Hazard Class | 6.1(a) |
| Packing Group | II |
FLUPHENAZINEDECANATE - Standard
Authoritative Data Verified Data
This product is 2-[4-[3-[2-(trifluoromethyl)] -10H-phenazin-10-yl] propyl]-1-piperazinyl] Ethanol decanoate. The content of C32H44F3N302S shall be between 98.0% and 102.0% calculated as dry.
Last Update：2024-01-02 23:10:35
FLUPHENAZINEDECANATE - Trait
Authoritative Data Verified Data
- This product is light yellow to yellow-brown viscous liquid; Light, dark color gradient.
- This product is highly soluble in methanol, ethanol, chloroform, anhydrous ether or vegetable oil, and is insoluble in water.
Last Update：2022-01-01 14:19:32
FLUPHENAZINEDECANATE - Differential diagnosis
Authoritative Data Verified Data
- Take 15~20mg of this product, add about 0.lg of sodium carbonate and potassium carbonate respectively, mix well, burn at 600°C for 15~20 minutes, let cool, add 2ml of water to dissolve, add hydrochloric acid solution (1-2) acidification, filtration, filtrate plus alizarin zirconium solution 0.5, should be yellow.
- take about 50mg of this product, add 2ml of methanol to dissolve, add 3ml of 0.1% palladium chloride solution, that is, there is precipitation, and red, plus an excess of palladium chloride solution, color darkening.
- take this product and add ethanol to make a solution containing lOug per 1 ml. According to ultraviolet-visible spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 260mn.
- The infrared absorption spectrum of this product is consistent with that of the control (Spectrum set 280).
Last Update：2022-01-01 14:19:33
FLUPHENAZINEDECANATE - Exam
Authoritative Data Verified Data
color of acetone solution
take the right amount of this product, add acetone to make 5% of the solution, and the Yellow No. 4 standard colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
Related substances
operation in the dark. New system was applied. Take about 10mg of this product, precision weighing, put it in 50ml measuring flask, add acetonitrile to dissolve and dilute to the scale, shake, as a test solution; Take 2ml, in A lOOml measuring flask, dilute to the scale with mobile phase A- mobile phase B(9:1), shake well and use as A control solution; Take an appropriate amount of fluphenazine hydrochloride reference (equivalent to 10mg of fluphenazine), add acetonitrile-water (95:5) to dissolve and dilute to the scale. Take 2ml and place it in 50ml measuring flask, dilute to the scale with acetonitrile-water (95:5) and shake well as a control solution. Take about 5mg of decafluphenazine control, add 30% of 0.1 hydrogen peroxide solution, mix with ultrasound, and place in a water bath at 50°C for 20 minutes to produce oxidative degradation products I and II, acetonitrile was added to dissolve and transferred to a 100ml measuring flask, diluted to the mark with acetonitrile, and shaken to serve as a system-suitable solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane is used as the filler (krolmasil C18,4.6mm X 250mm, 5um or the performance equivalent column; mobile phase A was acetonitrile-methanol (1:1 ) ; Mobile phase B was 0.5% ammonium carbonate solution (adjusted to pH 7.5 with dilute hydrochloric acid); The detection wavelength was 260nm; Gradient elution was performed according to the following table. The system applicable solution 20u1 was injected into the liquid chromatograph, and the peak order was degradation products I, II and decafluorphenazine. The retention time of decafluorphenazine was about 24 minutes, the relative retention time of II and decafluphenazine is about 0.58 and 0.66, and the separation degree between the two peaks of degradation product I and II should be greater than 2.0. The sample solution, the control solution and the reference solution were injected with 20 u1 respectively into the liquid chromatograph, and the chromatograms were recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of fluphenazine in the reference solution, the peak area shall not exceed 2.0% according to the external standard method; other single impurity peak area shall not be greater than 0.5 times (1.0%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than the main peak area of the control solution (2.0%).
loss on drying
take this product, after drying under reduced pressure at 60°C for 3 hours, the weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 14:19:34
FLUPHENAZINEDECANATE - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add glacial acetic acid dissolved in 20ml, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (0.1 mol/L) titration to the solution is blue-green, and the result of the titration is corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 29.59mg of C32H44F3N302S.
Last Update：2022-01-01 14:19:35
FLUPHENAZINEDECANATE - Category
Authoritative Data Verified Data
antipsychotics.
Last Update：2022-01-01 14:19:35
FLUPHENAZINEDECANATE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:19:35
FLUPHENAZINEDECANATE - Decafluorphenazine injection
Authoritative Data Verified Data
This product is decafluorphenazine sterilized oil solution. Decafluorphenazine (C32H44F3N302S) shall be included at 90.0% to 110.0% of label load.
trait
This product is a clear oily liquid from yellow to orange.
identification
- This product was taken and identified according to the item (2) and (3) of the item of decafluorphenazine, which showed the same results.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- the color of this product, compared with the yellow No. 10 Standard Colorimetric liquid (General Principles 0901 first method), should not be deeper.
- the related substances were protected from light. New system was applied. Take 2ml of this product with internal volume pipette, put it in 10ml measuring flask, add chloroform to dissolve and dilute to the scale, shake well, take 2ml with precision, put it in 50ml measuring flask, dilute to the scale with acetonitrile-chloroform (2:1), shake well, as a test solution; Take 2ml precision, put 100ml flask, with acetonitrile-chloroform (2:1) dilute to the scale, shake, as a control solution; Take an appropriate amount of fluphenazine hydrochloride reference (equivalent to 12mg of fluphenazine hydrochloride), Precision weighing, and put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take 1ml, put it in a 20ml measuring flask, add acetonitrile-chloroform (2:1) to dilute to the scale, shake well, as a control solution. According to the chromatographic conditions under the content determination item, the sample solution, the control solution and the reference solution were accurately measured, and the human liquid chromatograph was injected respectively, the chromatogram was recorded to 1.5 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of fluphenazine in the reference solution, 3.0% of the labeled amount of decafluphenazine shall not be calculated by the peak area according to the external standard method; other single impurity peak area shall not be greater than 1.5 times (3.0%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 4 times (8.0%) of the main peak area of the control solution.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (Inertsil ODS-3,4.6mm X 250mm,5um or equivalent performance column); the mobile phase was [1% ammonium carbonate solution-methanol (75:450), pH adjusted to 7.5±0.1 with acetic acid]-acetonitrile (525:450); The detection wavelength was 260nm. Take about 5mg of the reference substance of decafluphenazine, add 30% of 0.1 hydrogen peroxide solution, mix with ultrasound, and place in a water bath at 50°C for 20 minutes to produce oxidative degradation products I and II, add acetonitrile-chloroform (2:1) to dissolve and transfer to a 100ml measuring flask, dilute to scale with acetonitrile-chloroform (2:1), shake well, and inject 20ul into HPLC, the order of peak is degradation product I, II and decafluorphenazine, the retention time of decafluorphenazine is about 22 minutes, degradation product I, the relative retention time of II and decafluphenazine is about 0.50 and 0.56, and the separation degree between the two peaks of degradation product I and II should be greater than 2.0. The number of theoretical plates shall not be less than 5000 based on the peak of decafluphenazine.
- The assay was operated in the dark. Take 2ml of this product with internal volume pipette, put it in 50ml measuring flask, add chloroform to dissolve and dilute to scale, shake well; Take 5ml with precision, put it in 100ml measuring flask, add acetonitrile-chloroform (2:1) diluted to the scale, shake well, as a sample solution, the precision of 20u1 injection liquid chromatography, record chromatogram; add about 10mg of decafluphenazine control to a 100ml measuring flask, add an appropriate amount of acetonitrile-chloroform (2:1), shake to dissolve and dilute to scale, shake well, precision take 5ml, put 10ml flask, with acetonitrile-chloroform (2:1) diluted to the scale, shake, the same method. According to the external standard method to calculate the peak area, that is.
category
The same as that of decafluorphenazine.
specification
lml:25mg
storage
It was sealed and kept in a cool and dark place.
Last Update：2022-01-01 14:19:36
FLUPHENAZINEDECANATE - Reference Information
| pharmacological effects | fluphenazine's long-acting ester compounds have antipsychotic effects mainly related to its blocking of dopamine receptors (DA2) in the brain, inhibiting the reticular structure to activate the system and have sedative effects, antiemetic and blood pressure lowering effects are weak. |
| interaction | (1) this product is combined with ethanol or other central nervous system inhibitory drugs, and the central inhibitory effect is strengthened. (2) The combination of this product and antihypertensive drugs is easy to cause the risk of orthostatic hypotension. (3) This product is combined with sutopride, which is at risk of ventricular arrhythmia. In severe cases, it can cause torsion arrhythmia. (4) This product is combined with atropine drugs, and the adverse reactions are strengthened. (5) The combination of this product and lithium salt will cause loss of consciousness. |
| use | decafenazine is mainly used clinically for acute and chronic schizophrenia. It has an exciting effect on the symptoms of apathy and behavioral withdrawal of simple and chronic schizophrenia. It is also suitable for those who refuse to take drugs and patients who need long-term maintenance treatment. |
Last Update：2024-04-09 19:05:12
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Spot supply
Product Name: Fluphenazine Decanoate Visit Supplier Webpage Request for quotationCAS: 5002-47-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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