Haloperidol
Haloperidol
CAS: 52-86-8
Molecular Formula: C21H23ClFNO2
Haloperidol - Names and Identifiers
| Name | Haloperidol |
| Synonyms | Einalon Haloperidol 4-(4-hydroxy-4'-chloro-4-phenylpiperidino)-4'-fluorbutyrophenone 4-(4-(p-chlorophenyl)-4-hydroxypiperidino)-4'-fluorobutyrophenone 4-(4-(p-chlorophenyl)-4-hydroxypiperidino)-4'-fluoro-butyrophenon 4-(4-hydroxy-4'-chloro-4-phenylpiperidino)-4'-fluorobutyrophenone 4-(4-(p-Chlorophenyl)-4-hydroxypiperidino)-4'-fluorobutyrophenone 4-(4-(para-Chlorophenyl)-4-hydroxypiperidino)-4'-fluorobutyrophenone 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4-hydroxypiperidinium 4-(4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl)-1-(4-fluorophenyl)-1-butanon |
| CAS | 52-86-8 |
| EINECS | 200-155-6 |
| InChI | InChI=1/C21H23ClFNO2/c22-18-7-5-17(6-8-18)21(26)11-14-24(15-12-21)13-1-2-20(25)16-3-9-19(23)10-4-16/h3-10,26H,1-2,11-15H2/p+1 |
Haloperidol - Physico-chemical Properties
| Molecular Formula | C21H23ClFNO2 |
| Molar Mass | 375.86 |
| Density | 1.1820 (estimate) |
| Melting Point | 152 °C |
| Boling Point | 529.0±50.0 °C(Predicted) |
| Flash Point | 9℃ |
| Water Solubility | 2.058mg/L(22.5 ºC) |
| Solubility | 45% (w/v) aq 2-hydroxypropyl-β-cyclodextrin: 0.39mg/mL |
| Vapor Presure | 5.07E-12mmHg at 25°C |
| Appearance | powder |
| Color | white |
| Merck | 14,4598 |
| pKa | 8.3(at 25℃) |
| Storage Condition | 2-8°C |
| Physical and Chemical Properties | White or off-white crystalline powder. Melting point 148-149.4 °c. Soluble in chloroform, methanol, acetone, benzene, dilute acid, solubility in water 1.4mg/100ml, slightly soluble in ether. Odorless and tasteless. |
| Use | Has a strong anti-psychotic and anti-emetic effect, mainly used for anti-manic and anti-hallucination |
Haloperidol - Risk and Safety
| Risk Codes | R60 - May impair fertility R61 - May cause harm to the unborn child R25 - Toxic if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R43 - May cause sensitization by skin contact R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. 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. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | EU1575000 |
| HS Code | 2933399090 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 orally in rats: 165 mg/kg (Goldenthal); i.p. in mice: 60 mg/kg (Collins, Horlington) |
Haloperidol - Standard
Authoritative Data Verified Data
This product is l-(4-fluorophenyl)-4-[4-(4-chlorophenyl)]-4-hydroxy-1-piperidinyl]-1-dink. Calculated as the dried product, the content of C21H23C1FNO2 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
Haloperidol - Trait
Authoritative Data Verified Data
- This product is a self-color or off-white crystalline powder; Odorless.
- This product is dissolved in chloroform, slightly soluble in ethanol, slightly soluble in ether, almost insoluble in water.
melting point
The melting point of this product (General rule 0612 first method) is 149~153°C.
absorption coefficient
operation in the dark. Take an appropriate amount of this product, precision weighing, hydrochloric acid solution (9-100)-methanol (1:99) dissolved and quantitatively diluted into a solution containing about 15ug per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 338), and the absorption coefficient was 360.
Last Update：2022-01-01 13:40:51
Haloperidol - Differential diagnosis
Authoritative Data Verified Data
- take about 1 ml of saturated sulfuric acid solution of chromium trioxide, put it in a small test tube, turn the test tube, the solution should be evenly coated on the tube wall; Add about 2mg of this product, slightly warm, turn the test tube, the solution should not be evenly applied to the pipe wall, and similar oil scale exists in the pipe wall.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 281).
- take about 20mg of this product, according to the oxygen flask combustion method (General rule 0703) for organic destruction, with sodium hydroxide solution 5ml as the absorption liquid, after absorption is complete, after adding dilute nitric acid to make it acidic, slowly boil for 2 minutes, and the solution should identify the reaction of (1) (General 0301).
Last Update：2022-01-01 13:40:52
Haloperidol - Exam
Authoritative Data Verified Data
clarity of acidic solution
take this product 50mg, add lactic acid solution (0.5-100)10ml, heat dissolved, the solution should be clear.
Related substances
operation in the dark. Take about 50mg of this product, put it in a 50ml measuring flask, add the mobile phase and dilute it to the scale, shake it, and use it as a test solution. Take 1ml for precision measurement and put it in a 100ml measuring flask, quantitative dilution with mobile phase to the scale, shake, as a control solution. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as the filler; Methanol -0.05mol/L potassium dihydrogen phosphate solution (50:50)(PH adjusted to 4.0 with phosphoric acid) as mobile phase; The detection wavelength was 220nm. The retention time of the haloperidol peak is about 13 minutes, and the separation degree of the haloperidol peak from the adjacent impurity peak should meet the requirements. Accurately take 15 u1 of each of the control solution and the test solution, respectively inject into the liquid chromatograph, record the chromatogram to 2.5 times of the retention time of the main component peak, if there are impurity peaks in the chromatogram of the test solution, the single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
loss on drying
take this product, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 13:40:53
Haloperidol - Content determination
Authoritative Data Verified Data
take this product about 0.2g, precision weighing, add glacial acetic acid 20ml, slightly warm to dissolve, cool, add naphthol benzyl alcohol indicator solution 2 drops, with perchloric acid titration solution (O. 1 mol/L) titration to the solution is green, and the result of the titration is corrected with a blank test. Per 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 37.59mg of H23ClFNO2.
Last Update：2022-01-01 13:40:54
Haloperidol - Category
Authoritative Data Verified Data
antipsychotics.
Last Update：2022-01-01 13:40:54
Haloperidol - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:40:54
Haloperidol - Haloperidol tablets
Authoritative Data Verified Data
This product contains haloperidol (C21H23C1FNO2) should be 90.0% to 110.0% of the label.
trait
This product is sugar-coated tablets, White after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 2mg equivalent to haloperidol), add 2ml of chloroform, shake, filter, evaporate the filtrate, and test the residue according to item (1) of identification under haloperidol, the same reaction was shown.
- take the solution under the content determination item, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 244nm, there is minimal absorption at a wavelength of 232nm.
- take this product (about equivalent to haloperidol lOOmg), remove the sugar coating and grind it into a separatory funnel, add 20ml of water, 5ml of sodium hydroxide solution and 50ml of chloroform, and extract with shaking, after standing, the three-gas methane layer was filtered with cotton wool and evaporated to dryness, and the infrared absorption spectrum after drying the residue under reduced pressure at 60 ° C. For 4 hours should be consistent with the spectrum of the control (Spectrum set 281).
examination
- the related substances were protected from light. Take an appropriate amount of fine powder of this product (about equivalent to 10 mg of haloperidol), put it in a 10ml measuring flask, add an appropriate amount of mobile phase, sonicate haloperidol to dissolve, let it cool, dilute it to the scale with mobile phase, shake well, filter, the filtrate was taken as a test solution; 1 ml was accurately measured, placed in a 100ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The chromatographic peaks with relative retention time less than 0.25 and those less than 0.05 times of the main peak area of the control solution in the chromatogram of the test solution were ignored.
- Content uniformity protected from light. Take 1 tablet of this product, remove the coating, put it in the mortar, grind it fine, add 1 ml of hydrochloric acid solution (9-100), grind it for 2 minutes, transfer it to 50ml measuring flask in portions with methanol 30ml, heat and shake on a water bath to dissolve haloperidol, let it cool, dilute to scale with methanol, shake well, filter with dry filter paper, take 5ml of continued filtrate, put it in a 20ml measuring flask, dilute to the scale with hydrochloric acid solution (9-100)-methanol (1:99), shake well, and determine the content according to the method under the content determination item, which shall comply with the regulations (General rule 0941).
- dissolution rate protected from light. Take this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (9-1000) 100ml as the dissolution medium, speed is rpm, according to the law operation, after 30 minutes, take 10ml of the solution, filter, and take the continued filtrate as the test solution (2mg specification); Or take 5ml of the continued filtrate precisely and put it in a 10ml measuring flask, dilute to the scale with dissolution medium, shake, as test solution (4mg specification); Take another 10 mg of haloperidol control, precision weighing, put in 50ml measuring flask, add hydrochloric acid solution (9-100)-Methanol (1:99) dissolved and diluted to the scale, shake, precision take lml, 100ml flask, add hydrochloric acid solution (9-1000) diluted to the scale, shake, as a control solution. According to the chromatographic conditions under the item of haloperidol related substances, 50ul of each of the reference solution and the sample solution were accurately measured, and human liquid chromatograph was injected respectively to record the chromatogram, the dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
operation in the dark. Take 20 tablets of this product, remove the coating, precision weighing, fine, precision weighing an appropriate amount (about 10 mg equivalent to haloperidol), put it in a 100ml measuring flask, add hydrochloric acid solution (9-100)lml, after shaking for 2 minutes, add 60ml of methanol, heat and shake on a water bath to dissolve haloperidol, let it cool, dilute to scale with methanol, shake well, filter, and accurately take 10ml of continued filtrate, dilute the flask with hydrochloric acid solution (9-100)-methanol (1:99) to the standard, shake well, and perform UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 244nm and calculated as the absorption coefficient of C21H23C1FN02 was 353.
category
Same As haloperidol.
specification
(l)2mg (2)4mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:40:55
Haloperidol - Haloperidol injection
Authoritative Data Verified Data
This product is a sterile aqueous solution made of haloperidol and lactic acid. Haloperidol-containing (C21H23C1FN02) shall be between 90.0% and 110.0% of the nominal amount.
trait
This product is a clear colorless liquid.
identification
- 3 drops of this product were taken, and the same reaction was shown according to the test of item (1) under the item of haloperidol.
- light-shielding operation. The solution under the content measurement item was measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of 244mn and a minimum absorption at a wavelength of 232nm.
examination
- the pH value should be 2.8 to 3. 6 (General 0631).
- the related substances were protected from light. Measure 2ml of the product, put it in a 10ml measuring flask, dilute it to the scale with mobile phase, shake it, and use it as a test solution. Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be more than 0.5 times (0.5%) of the area of the main peak of the control solution; the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution. The chromatographic peaks with relative retention time less than 0.25 and those less than 0.05 times of the main peak area of the control solution in the chromatogram of the test solution were ignored.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per 1 mg haloperidol should be less than 10EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
operation in the dark. Precision take the right amount of this product, with hydrochloric acid solution (9-100)-methanol (1:99) quantitative dilution to prepare about 10ug of haloperidol solution per lml, the absorbance was measured at a wavelength of 244nm according to UV-Vis spectrophotometry (General rule 0401), and the absorption coefficient of C21H23C1FN02 was calculated as 353.
category
Same As haloperidol.
specification
lml : 5mg
storage
light shielding, closed storage.
Last Update：2022-01-01 13:40:56
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Spot supply
Product Name: Haloperidol Visit Supplier Webpage Request for quotationCAS: 52-86-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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