BETA-HISTINE DIHDROCHLORIDE
2-(2-(Methylamino)ethyl)pyridine dihydrochloride
CAS: 5579-84-0
Molecular Formula: C8H14Cl2N2
BETA-HISTINE DIHDROCHLORIDE - Names and Identifiers
BETA-HISTINE DIHDROCHLORIDE - Physico-chemical Properties
| Molecular Formula | C8H14Cl2N2 |
| Molar Mass | 209.12 |
| Melting Point | 150-154 °C |
| Boling Point | 210.9°C at 760 mmHg |
| Flash Point | 96.7°C |
| Solubility | Very soluble in water, soluble in ethanol (96 per cent), practically insoluble in 2propanol. |
| Vapor Presure | 0.187mmHg at 25°C |
| Appearance | White crystal |
| Color | Pale Yellow |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| MDL | MFCD00012813 |
| Physical and Chemical Properties | White or off-white crystals or crystalline powders. Melting point 150-154°C |
| Use | For the treatment of inner ear Vertigo (ie Meniere syndrome), cerebral arteriosclerosis, cerebral insufficiency and hypertension caused by Vertigo, Vomit and tinnitus. |
BETA-HISTINE DIHDROCHLORIDE - Risk and Safety
| Safety Description | 24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | UT2969000 |
| HS Code | 29333990 |
BETA-HISTINE DIHDROCHLORIDE - Standard
Authoritative Data Verified Data
This product is n-methyl-2-pyridylethanamine dihydrochloride. Calculated as dry product, containing C8H12N2 • 2HC1 shall not be less than 98.0%.
Last Update：2024-01-02 23:10:35
BETA-HISTINE DIHDROCHLORIDE - Trait
Authoritative Data Verified Data
- This product is white or off-white crystal or crystalline powder; Odorless; Easy deliquescence.
- This product is very soluble in water, slightly soluble in ethanol, and almost insoluble in acetone.
Last Update：2022-01-01 15:33:31
BETA-HISTINE DIHDROCHLORIDE - Differential diagnosis
Authoritative Data Verified Data
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 838).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:33:31
BETA-HISTINE DIHDROCHLORIDE - Exam
Authoritative Data Verified Data
acidity
take this product 0.lg, add water to dissolve, according to the law (General 0631),pH value should be 2.0~3.0.
clarity of the solution
take 0.lg of this product and add 10ml of water to dissolve. The solution should be clarified.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 0.4mg per 1ml as a test solution; Take 1ml for precision measurement and put it in a 200ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the high performance liquid chromatography (General 0512) test, silica gel was bonded with eighteen alkyl silane as filler; 0.01mOl/L sodium acetate buffer (containing 0.004mol/L sodium heptane sulfonate, 0.2% triethylamine, using glacial acetic acid to adjust the pH value to 3.3)-methanol (70:30) as mobile phase; The detection wavelength was 261mn. The theoretical plate number is not less than 3000 calculated as betahistine peak. 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 area of a single impurity peak shall not be greater than 0.4 times (0.2%) 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 (0.5%).
loss on drying
take this product, with phosphorus pentoxide as desiccant, at 100°C under reduced pressure drying to constant weight, loss of weight shall not exceed 1.0% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 15:33:32
BETA-HISTINE DIHDROCHLORIDE - Content determination
Authoritative Data Verified Data
take this product about 0.lg, precision weighing, add glacial acetic acid 20ml dissolved, add mercury acetate test solution 5ml and crystal violet indicator solution 1 drop, with high chlorine 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 10.46mg of C8H12N2 · 2HC1.
Last Update：2022-01-01 15:33:33
BETA-HISTINE DIHDROCHLORIDE - Category
Authoritative Data Verified Data
vasodilators.
Last Update：2022-01-01 15:33:33
BETA-HISTINE DIHDROCHLORIDE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:33:33
BETA-HISTINE DIHDROCHLORIDE - Betahistine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains betahistine hydrochloride (C8H12N2 • 2HC1) should be labeled the amount of 90.0% to 110.0%.
trait
This product is sugar-coated tablets, remove the coating, white or white.
identification
- take an appropriate amount of fine powder of this product (about 10 mg of Betahistine hydrochloride), add 1 drop of sodium nitroprusside test solution and 2 drops of 5% sodium carbonate solution, mix well, and put one piece of filter paper for use. Take another test tube, add about 0.5g of potassium bisulfate and 1-2 drops of glycerin. Put the above filter paper at the nozzle and heat it directly, the filter paper should be blue; Take the filter paper, A few drops of 2% sodium hydroxide solution were added, which turned red.
- the sample solution under the content uniformity was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of Nm.
- take the fine powder of this product, add water to dissolve betahistine hydrochloride, filter, filtrate chloride to identify (1) reaction (General 0301).
examination
- Content uniformity take 1 tablet of this product, remove the coating, put 50ml(4mg, 5mg specification) or 100ml (10 mg specification) measuring flask, add appropriate amount of hydrochloric acid solution (9-1000), shake, dissolve betahistine hydrochloride, dilute to the scale with hydrochloric acid solution (9-1000), shake well, filter, take 20ml of continued filtrate accurately and put it in a 100ml measuring flask, dilute to the scale with hydrochloric acid solution (9-1000), shake, as a test solution, UV-visible spectrophotometry (General 0401), at the wavelength of 261nm absorbance, the content calculated as the absorption coefficient of C8H12N2 • 2HC1 being 352 shall be in accordance with the regulations (General 0941).
- 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 with eighteen alkyl silane bonded silica gel as filler; O.Olmol/L sodium acetate buffer (containing 0.004mol/L sodium heptane sulfonate, 0.2% triethylamine, adjusted to pH 3.3 with glacial acetic acid)-methanol (70:30) as mobile phase; The detection wavelength was 261nm. The theoretical plate number is not less than 3000 calculated as betahistine peak.
- determination of 20 tablets of this product, after removing the coating, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to betahistine hydrochloride 4mg ), put it in a 100ml measuring flask, appropriate amount of mobile phase was added, and betahistine hydrochloride was dissolved by ultrasound. Dilute to scale with mobile phase, shake well, filter, take 20 ml continuous filtrate accurately, inject human liquid chromatograph, record chromatogram; separately take betahistine hydrochloride reference substance, precision weighing, plus mobile phase dissolution and quantitative dilution to make a solution containing about 40ug per 1 ml, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as betahistine hydrochloride.
specification
(l)4mg (2)5mg (3)10mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 15:33:34
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View History
BETA-HISTINE DIHDROCHLORIDE
Decyltrimethylammonium
Benzyl glyceryl acetal
Acetyl
Acid Naphthol Red G
PROFLOX
溴代癸烷
2219-30-9
100-00-5
Decyltrimethylammonium
Benzyl glyceryl acetal
Acetyl
Acid Naphthol Red G
PROFLOX
溴代癸烷
2219-30-9
100-00-5