Difenidol hydrochloride
diphenidol hydrochloride
CAS: 3254-89-5
Molecular Formula: C21H27NO
Difenidol hydrochloride - Names and Identifiers
| Name | diphenidol hydrochloride |
| Synonyms | DIPHENIDOL Difenidol HCL LABOTEST-BB LT00771934 Difenidol Hydrochloride DIFENIDOL HYDROCHLORIDE diphenidol hydrochloride DIPHENIDOL HYDROCHLORIDE 1,1-DIPHENYL-4-PIPERIDINO-1-BUTANOL HYDROCHLORIDE 1,1-diphenyl-4-(1-piperidyl)butan-1-ol hydrochloride alpha,alpha-diphenyl-1-piperidinebutanohydrochloride 1-(4-HYDROXY-4,4-DIPHENYLBUTYL)PIPERIDINE HYDROCHLORIDE |
| CAS | 3254-89-5 |
| EINECS | 221-850-0 |
| InChI | InChI=1/C21H27NO.ClH/c23-21(19-11-4-1-5-12-19,20-13-6-2-7-14-20)15-10-18-22-16-8-3-9-17-22;/h1-2,4-7,11-14,23H,3,8-10,15-18H2;1H |
Difenidol hydrochloride - Physico-chemical Properties
| Molecular Formula | C21H27NO |
| Molar Mass | 309.45 |
| Melting Point | 212-214° |
| Boling Point | 473.3°C at 760 mmHg |
| Flash Point | 233.5°C |
| Solubility | Soluble in ethanol, water |
| Vapor Presure | 9.19E-10mmHg at 25°C |
| Appearance | Crystal |
| Color | White to Off-White |
| Merck | 14,3311 |
| PH | pH (10g/l, 25℃) : 4.7～6.5 |
| Storage Condition | 2-8°C |
| Sensitive | Sensitive to light |
| MDL | MFCD00151479 |
| Use | Used as an antiemetic |
Difenidol hydrochloride - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | 36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | TM4970500 |
| Toxicity | LD50 oral in rat: 515mg/kg |
Difenidol hydrochloride - Standard
Authoritative Data Verified Data
This product is a,a-diphenyl-1-piperidinebutanol hydrochloride. The content of C21H27NO • HC1 shall not be less than 98.5% calculated as dry product.
Last Update：2024-01-02 23:10:35
Difenidol hydrochloride - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is soluble in methanol, soluble in ethanol, slightly soluble in water or chloroform.
melting point
The melting point of this product (General rule 0612 first method) is 217~222°C, and it is decomposed at the same time during melting.
Last Update：2022-01-01 14:22:32
Difenidol hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take 1~2mg of this product, add 1ml of water and 0.5ml of sulfuric acid, the solution shows yellow color, and the yellow color disappears after shaking.
- take about 5mg of this product, add 1ml of 1% acetic anhydride solution of Aconic acid, and heat it in a water bath for about 3 minutes. The solution shows Rose Red.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 338).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:22:32
Difenidol hydrochloride - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 5.0~7.0.
Related substances
take 25mg of this product, accurately weigh, put it in 50ml measuring flask, add appropriate amount of mobile phase, shake to dissolve, dilute to scale with mobile phase, shake well, as a test solution; another ENE compound (impurity I) reference substance 12.5mg, precision weighing, 50ml measuring flask, plus mobile phase dissolved and diluted to the scale, shake, as impurity I control solution; 1ml of each of the above two Solutions was accurately measured, placed in the same 100ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a control solution. Determined by high performance liquid chromatography (General 0512). Silica gel was bonded with eighteen alkyl silane as filler; 0.5% triethylamine solution (adjusted to pH 4.0 with phosphoric acid)-methanol (44:56) as mobile phase; Detection wavelength was 210nm. The number of theoretical plates shall not be less than 1500 calculated by diphenidol peak, and the separation degree between diphenidol peak and adjacent impurity peaks shall meet the requirements. 20 u1 of each of the control solution and the test solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 4 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and the peak area shall not exceed 0.5%, the sum of the peak areas of each other impurity shall not be greater than 0.5 times (0.5%) The Peak area of difenidol in the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 14:22:33
Difenidol hydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add glacial acetic acid 0701 to dissolve, add acetic anhydride 30ml, according to the potential titration method (general rule), titrate with perchloric acid titrant (0.1mol/L) and correct the titration results with a blank test. Each 1 ml perchloric acid titration solution (0.1 mol/L) corresponds to 34.59mg of C21H27NO. HCl.
Last Update：2022-01-01 14:22:34
Difenidol hydrochloride - Category
Authoritative Data Verified Data
antiemetics.
Last Update：2022-01-01 14:22:34
Difenidol hydrochloride - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 14:22:34
Difenidol hydrochloride - Difenidol Hydrochloride Tablets
Authoritative Data Verified Data
This product contains difenidol hydrochloride (C21H27NO • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is sugar-coated or film-coated tablet, White after removing the coating.
identification
- take 4 tablets of this product, grind, add ethanol 20ml, shake to dissolve difenidol hydrochloride, filter, evaporate the filtrate to dryness, and the residue is subjected to the following test.
- the same reaction was observed in the tests (1) and (2) for identification under the item difenidol hydrochloride.
- The residue was dissolved in water, and a test solution of dilute nitric acid and silver nitrate was added to form a white curd-like precipitate.
- 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
- appropriate amount of fine powder (equivalent to 25mg of difenidol hydrochloride) under the content determination item shall be accurately weighed, placed in a 50ml measuring flask, and the appropriate amount of mobile phase shall be added, followed by shaking to dissolve difenidol hydrochloride, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as the test solution; Take impurity I reference material 25mg, precision weighing, put in 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as impurity I control solution; Respectively, take the above two solutions of 1ml, put in the same 100ml measuring flask, dilute to the scale with mobile phase, as a control solution. If there are chromatographic peaks consistent with the retention time of impurity I in the chromatogram of the test solution determined by the method for related substances of difenidol hydrochloride, the peak area shall be calculated according to the external standard method, 1.0% of the labeled amount of difenidol hydrochloride shall not be passed, and the sum of the peak areas of other impurities shall not be greater than the peak area of difenidol hydrochloride in the control solution (1.0%).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, take the solution, filter, take the filtrate as the test solution; According to the chromatographic conditions under the content determination item, take the sample solution 20 u1 accurately, injection of human liquid chromatography, record chromatogram; Another difenidol hydrochloride control about 12.5mg, precision weighing, plus mobile phase dissolution and quantitative dilution of prepared solution containing 25ug per lml, the same method for determination. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 75% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; With 0.5% triethylamine solution (with phosphoric acid to adjust the pH value to 4.0)-methanol (44:56) as mobile phase; the detection wavelength was 210nm. The number of theoretical plates shall not be less than 1500 calculated by diphenidol peak, and the separation degree between diphenidol peak and adjacent impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, after removing the coating, precision weighing, fine grinding, precision weighing fine powder appropriate amount (equivalent to difenidol hydrochloride 25mg ), put in 50ml measuring flask, add appropriate amount of mobile phase, shake to dissolve difenidol hydrochloride and dilute to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in a 100ml measuring flask, dilute to the scale with mobile phase, after shaking well, as the test solution, 20u1 was injected into the liquid chromatograph with precise volume, and the chromatogram was recorded. Another reference substance of difenidol hydrochloride, about 12.5mg, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 25ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category storage
Same as difenidol hydrochloride.
specification
25mg
Last Update：2022-01-01 14:22:35
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