Flunarizine hydrochloride
flunarizine dihydrochloride
CAS: 30484-77-6
Molecular Formula: C26H26F2N2·2HCl
Flunarizine hydrochloride - Names and Identifiers
| Name | flunarizine dihydrochloride |
| Synonyms | Flunarizine, DiHCl Flunarizine hydrochloride flunarizine dihydrochloride 1-[bis(4-fluorophenyl)methyl]-4-[(2E)-3-phenylprop-2-en-1-yl]piperazine 1-[bis(4-fluorophenyl)methyl]-4-[(2E)-3-phenylprop-2-en-1-yl]piperazinediium 1-(bis(4-fluorophenyl)methyl)-4-(3-phenyl-2-propenyl)piperazine dihydrochloride |
| CAS | 30484-77-6 |
| EINECS | 250-216-6 |
| InChI | InChI=1/C26H26F2N2/c27-24-12-8-22(9-13-24)26(23-10-14-25(28)15-11-23)30-19-17-29(18-20-30)16-4-7-21-5-2-1-3-6-21/h1-15,26H,16-20H2/p+2/b7-4+ |
Flunarizine hydrochloride - Physico-chemical Properties
| Molecular Formula | C26H26F2N2·2HCl |
| Molar Mass | 477.42 |
| Melting Point | 204-210℃ |
| Boling Point | 511.3°C at 760 mmHg |
| Flash Point | 263°C |
| Solubility | Soluble in DMSO (25 mg/mL), ethanol (5 mg/mL warm), methanol, 0.1N HCI, and chloroform/ |
| Vapor Presure | 1.43E-10mmHg at 25°C |
| Appearance | White crystalline powder, odorless |
| Storage Condition | 2-8℃ |
| MDL | MFCD00058198 |
| Use | For the treatment of cerebrovascular diseases |
Flunarizine hydrochloride - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed |
Flunarizine hydrochloride - Standard
Authoritative Data Verified Data
This product is [bis-(4-fluorophenyl) methyl]-4-(2-propenyl-3-phenyl) piperazine dihydrochloride. The content of C26H26F2N2 • 2HC1 shall be between 99.0% and 101.5% based on the dry product.
Last Update：2024-01-02 23:10:35
Flunarizine hydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline or crystalline powder; Odorless.
- This product is slightly soluble in methanol or ethanol, slightly soluble in chloroform, and slightly soluble in water.
Last Update：2022-01-01 15:07:15
Flunarizine hydrochloride - Introduction
Flunarizine 2HCl is a dihydrohydrochloride salt that inhibits calcium ion channels with a Ki of 68 nM.
Last Update：2022-10-16 17:24:26
Flunarizine hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 3ml ethanol, shake to dissolve, add 2 drops of potassium hydroxide solution, shake well, add 1 drop of potassium permanganate solution, purple color disappeared immediately.
- take about 6mg of this product, add 5ml of ethanol and hydrochloric acid solution (take 24ml of dilute hydrochloric acid and add water to 1000ml), dissolve 5ml, shake well, take appropriate amount, add the above hydrochloric acid solution to make a solution containing 12ug per 1 ml, which has the maximum absorption at the wavelengths of 226nm and 253nm as determined by ultraviolet-visible spectrophotometry (General rule 0401), there is minimal absorption at the wavelength of 221nm and 234nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 379).
- take about 5mg of this product and dissolve it with 1 ml of ethanol. Identify (1) reaction of chloride (General rule 0301).
Last Update：2022-01-01 15:07:16
Flunarizine hydrochloride - Exam
Authoritative Data Verified Data
acidity
take 0.25g of this product, add water 20ml, stir for 5 minutes, filter, take the filtrate to determine according to law (General 0631),pH value should be 1.5~3.0.
clarity and color of solution
take 2.5g of this product, put it in a 25ml measuring flask, add an appropriate amount of polyethylene glycol 400-water-ethanol (5:2:3), ultrasonic to dissolve and dilute to the scale, shake well, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the turbidity standard solution No. 1 (General rule 0902, Method 1); If it is colored, according to UV-Vis spectrophotometry (General rule 0401), absorbance was measured at a wavelength of 400nm, not more than 0.07.
Related substances
take this product, add mobile phase to dissolve and dilute to make about O in each lml. 1 mg of the solution was used as the test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to a solution containing about 1 ug per 1 ml, which was used as a control solution. Test according to high performance liquid chromatography (General 0512). Silica gel was bonded with eighteen alkyl silane as filler; Methanol-phosphate buffer solution (1.36g of potassium dihydrogen phosphate, dissolved in water and diluted to 1000ml, triethylamine 4ml, pH adjusted to 3.5:75 with phosphoric acid: 25) as mobile phase; The detection wavelength was 253nm. The number of theoretical plates shall not be less than 3000 calculated by flunarizine peak; The separation degree between flunarizine peak and adjacent impurity peaks shall meet the requirements. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 15:07:17
Flunarizine hydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.2g, precision weighing, add ethanol 70ml dissolved, according to the potential titration method (General 0701), with sodium hydroxide titration solution (O. 1 mol/L) titration, calculated as the volume of the titration solution consumed at the second burst point, and the titration result was corrected by a blank test. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 23.87mg of C26H26F2N2 · 2HC1.
Last Update：2022-01-01 15:07:17
Flunarizine hydrochloride - Category
Authoritative Data Verified Data
vasodilators.
Last Update：2022-01-01 15:07:17
Flunarizine hydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:07:17
Flunarizine hydrochloride - Flunarizine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains flunarizine hydrochloride according to flunarizine (C26H26F2N2) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (equivalent to 50mg of flunarizine), add 10ml of ethanol, fully shake to dissolve flunarizine hydrochloride, filter, and take 2ml of filtrate, add 2 drops of potassium hydroxide test solution, shake well, add 1-2 drops of potassium permanganate test solution, and the purple color disappears immediately.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution is consistent with the retention time of the main peak of the control solution.
- take the test solution under the content determination item, according to ultraviolet-visible spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 226nm and 253nm, there is minimal absorption at the wavelength of 221nm and 234nm.
- 1ml of the filtrate under identification (1) was taken to show the reaction of chloride identification (1) (General 0301).
examination
-
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).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (dilute hydrochloric acid 24ml and water to 1000ml)600ml as the dissolution medium, the rotation speed is 100 rpm, and the operation is carried out according to law. After 30 minutes, take an appropriate amount of the solution, filter it, and take the filtrate according to ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 253nm, and the elution amount per sheet was calculated as the absorption coefficient of C26H25F2N2 · 2HC1 was 439, and the result was multiplied by 0.8473. 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler, methanol-phosphate buffer (take potassium dihydrogen phosphate 1.36g, dissolve and dilute with water to make 1000ml, add triethylamine 4ml, adjust the pH to 3 with phosphoric acid. 5x 75:25) as mobile phase, the detection wavelength was 253nm. The number of theoretical plates shall not be less than 3000 calculated by flunarizine peak; The separation degree between flunarizine peak and adjacent impurity peaks shall meet the requirements.
- determination Method: Take 10 tablets of this product, put them in 100ml measuring flasks, add 5ml of ethanol and 5ml of hydrochloric acid solution (take 24ml of dilute hydrochloric acid and add water to 1000ml), and sonicate flunarizine hydrochloride to dissolve, dilute to the scale with the above hydrochloric acid solution, shake well, filter, take 10ml of the continuous filtrate accurately, put it in a 50ml measuring flask, dilute to the scale with the above hydrochloric acid solution, shake well, as a test solution; Take the right amount of flunarizine hydrochloride reference, precision weighing, add 10ml ethanol, shake to dissolve, A solution containing 10ug of fluorine-containing cinnarizine per 1 ml was prepared by quantitative dilution with the above hydrochloric acid solution as a reference solution. Accurately take 20ul of the test solution and the reference solution, respectively inject into the liquid chromatograph, record the chromatogram, calculate the content of each tablet by peak area according to the external standard method, and obtain the average content of 10 tablets, that's right.
category
with flunarizine hydrochloride.
specification
5mg (based on C26H26F2N2)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:07:18
Flunarizine hydrochloride - Flunarizine Hydrochloride Dispersible Tablets
Authoritative Data Verified Data
This product contains flunarizine hydrochloride according to flunarizine (C26H26F2N2) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (equivalent to 50mg of flunarizine), add 10ml of ethanol, fully shake to dissolve flunarizine hydrochloride, filter, and take 2ml of filtrate, add 2 drops of potassium hydroxide test solution, shake well, add 1-2 drops of potassium permanganate test solution, and the purple color disappears immediately.
- 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.
- take the test solution under the content determination item, according to ultraviolet-visible spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 226nm and 253mn, there is minimal absorption at the wavelength of 221nm and 234nm.
- 1ml of the filtrate under identification (1) was taken to show the reaction of chloride identification (1) (General 0301).
examination
-
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).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (dilute hydrochloric acid 24ml and water to 1000ml)600ml as the dissolution medium, the rotation speed is 100 rpm, and the operation is carried out according to law. After 10 minutes, take an appropriate amount of the solution, filter it, and take the filtrate according to ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 253nm, and the elution amount per sheet was calculated as the absorption coefficient of C26H25F2N2 · 2HC1 was 439, and the result was multiplied by 0.8473. The limit is 85% 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 methanol phosphate buffer (take potassium dihydrogen phosphate 1.36g, dissolve and dilute with water to 1000ml, add triethylamine 4ml, adjust the pH to 3 with phosphoric acid. 5x 75:25) as mobile phase, the detection wavelength was 253nm. The number of theoretical plates shall not be less than 3000 calculated by flunarizine peak; The separation degree between flunarizine peak and adjacent impurity peaks shall meet the requirements.
- determination Method: Take 10 tablets of this product, put them in 100ml measuring flasks, add 5ml of ethanol and 5ml of hydrochloric acid solution (take 24ml of dilute hydrochloric acid and add water to 1000ml), and dissolve flunarizine hydrochloride by ultrasound, dilute to the scale with the above hydrochloric acid solution, shake well, filter, take 10ml of the continuous filtrate accurately, put it in a 50ml measuring flask, dilute to the scale with the above hydrochloric acid solution, shake well, as a test solution; Take the right amount of flunarizine hydrochloride reference, precision weighing, add 10ml ethanol, shake to dissolve, quantitative dilution with the above hydrochloric acid solution was carried out to prepare a solution containing 10 tons of fluorine-containing Gui-Liyan per 1 ml as a reference solution. Accurately take 20ul of the test solution and the reference solution, respectively inject into the liquid chromatograph, record the chromatogram, calculate the content of each tablet by peak area according to the external standard method, and obtain the average content of 10 tablets, that's right.
category
with flunarizine hydrochloride.
specification
5mg (based on C26H26F2N2)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:07:19
Flunarizine hydrochloride - Flunarizine Hydrochloride Capsules
Authoritative Data Verified Data
This product contains flunarizine hydrochloride according to flunarizine (C26H26F2N2) calculation, should be 90.0% ~ 110.0% of the label amount.
identification
- take an appropriate amount of the content of this product (about 50mg of flunarizine hydrochloride), add 10ml of ethanol, fully shake, dissolve flunarizine hydrochloride, filter, take 2ml of filtrate, add 2 drops of potassium hydroxide test solution, shake well, add 1-2 drops of potassium permanganate test solution, and the purple color disappears immediately.
- 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.
- take the solution under the content determination item, according to ultraviolet-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 226nm and 253nm, there is minimal absorption at the wavelength of 221nm and 234nm.
- 1ml of the filtrate under identification (1) was taken to show the reaction of chloride identification (1) (General 0301).
examination
- Content uniformity take 1 capsule of this product, pour the content into a 100ml measuring flask, add 5ml ethanol, shake to dissolve flunarizine hydrochloride, add hydrochloric acid solution (dilute hydrochloric acid 24ml with water to 1000ml), dilute to the scale, shake well, filter, accurately take 10ml of continued filtrate, put it in 50ml measuring flask, dilute the above hydrochloric acid solution to the scale, shake well. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution: Take 1 capsule of this product, and use 0931 of hydrochloric acid solution (24ml of dilute hydrochloric acid and water to ML) as dissolution medium according to the dissolution and release determination method (General rule 1 method 1), the rotation speed is 100 rpm, and the operation is carried out according to law. After 30 minutes, 10ml of the solution is taken, filtered, and the filtrate is taken as the test solution. The dissolution amount of each pellet was calculated as measured by the method under the content measurement item. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
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, methanol-phosphate buffer (take potassium dihydrogen phosphate 1.36g, dissolve with water and dilute to 1000ml, add triethylamine 4ml, the mobile phase was adjusted to pH 3.5 with phosphoric acid (75:25); The detection wavelength was 253nm. The number of theoretical plates shall not be less than 3000 calculated by flunarizine peak; The separation degree between flunarizine peak and adjacent impurity peaks shall meet the requirements.
- determination of this product 20 capsules, precision weighing, calculate the average loading, take the content, mixed evenly, precision weighing appropriate amount (equivalent to flunarizine 10mg ), in a 100ml measuring flask, add 10ml of ethanol, shake to dissolve flunarizine hydrochloride, dilute to the scale with hydrochloric acid solution (24ml of dilute hydrochloric acid and water to 1000ml), shake and filter, precisely take 5ml of continued filtrate, put it in a 50ml measuring flask, dilute it to the scale with the above hydrochloric acid solution, shake it well, and use it as a test solution, 10ml of ethanol was added, dissolved by shaking, and quantitatively diluted with the above hydrochloric acid solution to prepare a solution containing fluorine cinnarizine lOug per 1 ml as a control solution. The sample solution and the reference solution of 20 u1 were respectively injected into the human liquid chromatograph, and the chromatogram was recorded. The peak area was calculated according to the external standard method.
category
with flunarizine hydrochloride.
specification
5mg (based on C26H26F2N2)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:07:20
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View History
Flunarizine hydrochloride
乙二酸二锂盐
巴龙霉素硫酸盐
3-溴丙酸叔丁酯
5-氧代-L-脯氨酰肼
4-硝基-邻甲酚
ethyl alpha-propylcyclopentaneacetate
ACETOACET-P-CHLOROANILIDE
萘丁美酮杂质02
苄基溴化镁 1M THF
乙二酸二锂盐
巴龙霉素硫酸盐
3-溴丙酸叔丁酯
5-氧代-L-脯氨酰肼
4-硝基-邻甲酚
ethyl alpha-propylcyclopentaneacetate
ACETOACET-P-CHLOROANILIDE
萘丁美酮杂质02
苄基溴化镁 1M THF