a4077
Fluphenazine hydrochloride
CAS: 146-56-5
Molecular Formula: C22H28Cl2F3N3OS
a4077 - Names and Identifiers
| Name | Fluphenazine hydrochloride |
| Synonyms | a4077 liogen anatensol flufenazin Fluphenazine HCL Fluphenazine hydrochloride fluphenazine dihydrochloride 4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazineethanodihy 4-[3[2-(trifluoromethyl)-10h-phenothiazin-10-yl]propyl]-1-piperazineethano 10-(3-(4-(2-hydroxyethyl)piperazinyl)propyl)-2-trifluoromethylphenothiazine 4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazineethanol,dihy 2-(4-{3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl]propyl}piperazin-1-yl)ethanol dihydrochloride |
| CAS | 146-56-5 |
| EINECS | 205-674-1 |
| InChI | InChI=1/C22H26F3N3OS.ClH/c23-22(24,25)17-6-7-21-19(16-17)28(18-4-1-2-5-20(18)30-21)9-3-8-26-10-12-27(13-11-26)14-15-29;/h1-2,4-7,16,29H,3,8-15H2;1H |
a4077 - Physico-chemical Properties
| Molecular Formula | C22H28Cl2F3N3OS |
| Molar Mass | 510.44 |
| Melting Point | 200-2020C |
| Boling Point | 568.3°C at 760 mmHg |
| Flash Point | 297.5°C |
| Solubility | Soluble in DMSO and methanol. |
| Vapor Presure | 9.41E-14mmHg at 25°C |
| Appearance | neat |
| Color | White to Light yellow |
| Storage Condition | 2-8°C |
| Sensitive | Hygroscopic |
| MDL | MFCD00055212 |
| Physical and Chemical Properties | White or white crystalline powder, melting point 226-233 C (decomposition). Soluble in water, slightly soluble in ethanol, very slightly soluble in acetone, insoluble in benzene, ether, odorless, slightly bitter taste, light easy to change color. Fluoride and static alkali ([69-23-8]) are dark brown oily liquids, boiling point 268-274 ℃(66.5). |
| Use | For the treatment of acute and chronic schizophrenia, mania, neurosis and Vomit |
a4077 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S36 - Wear suitable protective clothing. |
| UN IDs | UN2811 |
| WGK Germany | 3 |
| RTECS | TL9800000 |
| HS Code | 2934302300 |
| Hazard Class | 6.1 |
| Packing Group | III |
a4077 - Standard
Authoritative Data Verified Data
This product is 4-[3-[2-(trifluoromethyl)-10h-phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The content of C22H26F3N30S • 2HC1 shall be between 98.0% and 102.0% calculated as dry.
Last Update：2024-01-02 23:10:35
a4077 - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless; Easy to change color when exposed to light.
- This product is soluble in water, slightly soluble in ethanol, very slightly soluble in acetone, insoluble in ether.
absorption coefficient
take this product, precision weighing, and hydrochloric acid solution (9- 1000) dissolved and quantitatively diluted into about 10ug solution per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 553), and the absorption coefficient was 593.
Last Update：2022-01-01 15:07:10
a4077 - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 1.959 ml | 9.795 ml | 19.591 ml |
| 5 mM | 0.392 ml | 1.959 ml | 3.918 ml |
| 10 mM | 0.196 ml | 0.98 ml | 1.959 ml |
| 5 mM | 0.039 ml | 0.196 ml | 0.392 ml |
Last Update：2024-01-02 23:10:35
a4077 - Differential diagnosis
Authoritative Data Verified Data
- take 5mg of this product, add 5ml of sulfuric acid to dissolve, that is, light red; After warming, it turns red-brown.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 378).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:07:11
a4077 - Exam
Authoritative Data Verified Data
acidity
take this product l.Og, add water 20ml to dissolve, according to the law (General 0631),pH value should be 1.9~2.3.
Related substances
take an appropriate amount of this product, add mobile phase A to dissolve and dilute to make A solution containing about 0.4mg per lml as A test solution; Take 1ml for precision measurement and put it in A 100ml measuring flask, dilute to the scale with mobile phase A and shake well as A control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the control solution and the test solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%), the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 80°C, 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 15:07:12
a4077 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with a Eighteen alkyl silane as a filler; O.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 2.5 with phosphoric acid)-methanol-acetonitrile (52:28:20) as mobile phase A; Methanol-acetonitrile (58:42) as the mobile phase B, the gradient elution was carried out according to the following table; The detection wavelength was 259nm; The number of theoretical plates was not less than 3000 according to the peak of fluphenazine hydrochloride.
assay
take about 20mg of this product, precision weighing, put it in 50ml measuring flask, add mobile phase A to dissolve and dilute to the scale, shake, take 10ml, put it in 50ml measuring flask, dilute to the scale with mobile phase A, shake, as A test solution, take 20u1 injection of human liquid chromatography with precision, record the chromatogram; Take the fluphenazine hydrochloride control, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:07:12
a4077 - Category
Authoritative Data Verified Data
antipsychotics.
Last Update：2022-01-01 15:07:13
a4077 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:07:13
a4077 - Fluphenazine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains fluphenazine hydrochloride (C22H26F3N30S • 2HC1) should be 90.0% ~ 110.0% of the label amount.
trait
This product is sugar-coated tablets, White after removing the coating.
identification
- take this product, remove the coating, dilute, weigh an appropriate amount (equivalent to 30mg of fluphenazine hydrochloride), add 15ml of ethanol, shake to dissolve the fluphenazine hydrochloride, filter, and evaporate the filtrate to dryness; the residue showed the same reaction according to the tests (1) and (4) for the identification of fluphenazine hydrochloride.
- 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
- Related substances take 20 tablets of this product, remove the coating, precision weighing, fine grinding, precision weighing to take appropriate amount, add mobile phase A to dissolve and dilute to make A solution containing 0.4mg of fluphenazine hydrochloride per 1ml, shake well, filter, and take the continued filtrate as the test solution, set in A 100ml measuring flask, dilute to the scale with mobile phase A, and shake to serve as A control solution. If there are impurity peaks in the chromatogram of the test solution, the peaks with relative retention time less than 0.2 shall be excluded, the single impurity peak area shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 10 tablets of this product, remove the coating, put them in 25ml measuring flask respectively, add appropriate amount of mobile phase A, ultrasonic dissolve fluphenazine hydrochloride, dilute to scale with mobile phase A, shake well, after filtering, the filtrate was taken as a test solution, and the content of each tablet was measured according to the method of measuring the content of fluphenazine hydrochloride, and the average content of 10 tablets was obtained.
category
with fluphenazine hydrochloride.
specification
2mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:07:13
a4077 - Fluphenazine hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of fluphenazine hydrochloride. Containing fluphenazine hydrochloride (C22H26F3N3OS • 2HC1) shall be between 95.0% and 110.0% of label load.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (equivalent to 20mg of fluphenazine hydrochloride), add about lOOmg of sodium carbonate and potassium carbonate respectively, mix well, carefully heat with small fire and evaporate to dryness, then it was ash at 600 ° C., dissolved by adding 2ml of water, acidified by adding hydrochloric acid (1:2), filtered, and 0.5ml of alizarin zirconium test solution was added to the filtrate, and the solution turned from red to yellow.
- take an appropriate amount of this product (about equivalent to 3mg of fluphenazine hydrochloride), add a few drops of sulfuric acid, that is, red and yellow, and turn green after heating.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 4.5 to 5.5 (General 0631).
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product (about 1Omg equivalent to fluphenazine hydrochloride), put it in A 50ml measuring flask, dilute it to the scale with mobile phase A, shake well, and take 10ml in A precise amount, in A 25ml measuring flask, dilute to the scale with mobile phase A, shake well, as A test solution, and measure according to the method under the item of measuring the content of fluphenazine hydrochloride.
category
with fluphenazine hydrochloride.
specification
2ml:1Omg
storage
shading and preservation.
Last Update：2022-01-01 15:07:14
a4077 - Reference Information
| EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
| action | pharmacological action and mechanism are similar to chlorpromazine and perphenazine, but its characteristics are that antipsychotic effect is 4 times stronger than perphenazine, 20-40 times stronger than chlorpromazine, and the effect is rapid and lasting, the antiemetic effect is also strong, and the antihypertensive and hypnotic effects are weak. It is clinically used in the treatment of schizophrenia and can improve the uplifting mood of chronic patients. Fluphenazine decanoate is a long-acting ester compound of fluphenazine, which takes 9-20 times longer than fluphenazine. |
| indication | is suitable for maintenance treatment and chronic schizophrenia, and can be used as the first choice for patients who refuse drugs and Tibetan drugs. |
| preparation | fluphenazine hydrochloride is prepared by two-step reaction. in the first step, 1-(3-chloropropyl)-4-(2-hydroxyethyl) piperazine is prepared with hydroxyethyl piperazine and 1,3-bromochloropropane as starting materials. fluphenazine hydrochloride is directly reacted with trifluoromethyl phenothiazine under alkaline conditions without post-treatment. The synthesis reaction formula is as follows: |
| biological activity | Fluphenazine dihydrochloride (Prolixin) are D1DR and D2DR inhibitors of phenothiazines. It can inhibit histamine H1 receptor. |
| use | strong sedative. It is said that it should be used for acute and chronic schizophrenia, which has a significant effect on paranoia and tension. used to treat acute and chronic schizophrenia, mania, neurosis and vomiting, etc. |
Last Update：2024-04-09 21:21:28
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