50-98-6
(1R,2S)-(-)-Ephedrine hydrochloride
CAS: 50-98-6
Molecular Formula: C10H16ClNO
50-98-6 - Names and Identifiers
50-98-6 - Physico-chemical Properties
| Molecular Formula | C10H16ClNO |
| Molar Mass | 201.693 |
| Melting Point | 217-220℃ |
| Boling Point | 255°C at 760 mmHg |
| Flash Point | 85.6°C |
| Vapor Presure | 0.00865mmHg at 25°C |
| Use | For the prevention of bronchial asthma and mild asthma relief |
50-98-6 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed |
| Safety Description | S22 - Do not breathe dust. S23 - Do not breathe vapour. |
50-98-6 - Nature
Open Data Verified Data
colorless waxy solid or crystalline particles. Molecular weight of 165.24, melting point of 40 degrees Celsius, boiling point of 225 degrees Celsius, flash point of 85 degrees Celsius. Soluble in water, soluble in ethanol, ether, chloroform. Its aqueous solution is alkaline. The commercial form is usually ephedrine hydrochloride, which is a white needle-like crystal or crystalline powder with a melting point of 218 °c. Soluble in water, ethanol, insoluble in ether and chloroform. Ephedrine extracted from ephedra is levorotatory, and ephedrine obtained by chemical synthesis is racemic.
Last Update：2024-01-02 23:10:35
50-98-6 - Preparation Method
Open Data Verified Data
- ephedrine can be extracted from Herba ephedrae. The stems and branches of Herba ephedrae were cut into 2-4cm length, added with 7 times the amount of water, and soaked and boiled for 5 times with 0.15 MPA hot pressing for a total of 16h to obtain an aqueous solution containing Total alkaloids of Herba ephedrae. The decoction was basified with sodium hydroxide to pH 12 and then extracted with 2-fold amount of toluene at 60-70 °c. Add 2% oxalic acid solution to the toluene extract, so that the toluene layer pH is 7, and the total alkaloids in the toluene extract are transferred to the oxalic acid solution, the toluene layer was separated to give a dilute solution of the total alkaloids of ephedra in oxalate. The dilute oxalic acid solution containing alkaloids was concentrated under reduced pressure at 70 ℃ and cooled to 30 ℃. The solubility of ephedrine oxalate in water was small. The mother liquor contains pseudoephedrine oxalate.
- add 8~10 times of water and 1. 5% activated carbon, boiling, filtration, filtrate under stirring add calcium chloride solution to no longer produce precipitation or turbidity, can be obtained ephedrine hydrochloride solution. Then, add sodium sulfide solution to pH 7.5~8, and settle to precipitate calcium oxalate, iron sulfide and other impurities. After filtration, take the supernatant and hydrochloric acid to adjust to pH 6~6.5, and filter with suction, the solution was concentrated under reduced pressure, cooled to 30 ° C., crystallized, centrifuged and dried to obtain a finished product.
- The above mother liquor containing pseudoephedrine oxalate can be alkalized with sodium hydroxide to separate pseudoephedrine. After acylation, translocation, hydrolysis and neutralization, The Crystal of ephedrine oxalate can be obtained, ephedrine hydrochloride can be obtained by treatment as described above.
Last Update：2022-01-01 11:15:18
50-98-6 - Standard
Authoritative Data Verified Data
This product is [R-(R,S)]-a-[l-(methylamino) ethyl] benzyl alcohol hydrochloride. The content of C10H15NO. HC1 shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
50-98-6 - Trait
Authoritative Data Verified Data
- This product is white needle-like crystal or crystalline powder; Odorless.
- This product is soluble in water, soluble in ethanol, insoluble in chloroform or ether.
melting point
The melting point of this product (General 0612) is 217~220°C.
specific rotation
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 50mg per lml, and determine according to law (General 0621), the specific rotation was -33 ° to -35.5 °.
Last Update：2022-01-01 15:34:00
50-98-6 - Use
Open Data Verified Data
ephedrine for adrenergic drugs. Can stimulate the sympathetic nerve, the effect of adrenaline lasting; Can relax bronchial smooth muscle, contraction of blood vessels; Significant central excitation. Clinical mainly for the treatment of habitual bronchial asthma and prevention of asthma attacks. For severe bronchial asthma treatment effect is less than epinephrine, but for nasal congestion and Nasal Congestion, the treatment effect is better than epinephrine.
Last Update：2022-01-01 11:15:19
50-98-6 - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 1ml of water to dissolve, add 2 drops of copper sulfate test solution and 1ml of 20% sodium hydroxide solution, that is blue purple; Add 1ml of ether, shake, place, the ether layer is purplish red and the water layer turns blue.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 387).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:34:00
50-98-6 - Exam
Authoritative Data Verified Data
clarity of the solution
take l.Og of this product, add water 20ml to dissolve, the solution should be clarified.
pH
take this product l. After adding 20ml of water to dissolve, add 1 drop of Methyl red indicator solution, such as yellow, add sulfuric acid titration solution (O.Olmol/L)O.10ml, strain is red; If light red, add sodium hydroxide titration solution (0.02mol/L)0.10, strain is yellow.
sulfate
take l.Og of this product and check it according to law (General rule 0802). Compared with the control solution made of 1.0ml of standard potassium sulfate solution, it should not be more concentrated (0.010%).
Related substances
take about 50mg of this product, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as a test solution; Take 1ml for precision measurement, put it in a 100ml measuring flask, dissolve and dilute to the scale with the mobile phase, shake well, and serve as a control solution. According to the high performance liquid chromatography (General rule 0512) test, silica gel was bonded with eighteen alkyl silane as the filler; Phosphate buffer solution (6.8g of potassium dihydrogen phosphate, triethylamine 5ml, phosphoric acid 4ml, add water to ML, dilute phosphoric acid or triethylamine was used to adjust the pH value to 3.0±0.1)-acetonitrile (90:10) as mobile phase; The detection wavelength was 210nm. The number of theoretical plates shall not be less than 3000 calculated as the peak of ephedrine hydrochloride. l0ul of the control solution and the test 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 0.5 times (0.5%) of the main peak area of 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).
Heavy metals
take l.Og of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (General rule 0821 first law), containing heavy metals not more than 20 parts per million.
Last Update：2022-01-01 15:34:01
50-98-6 - Content determination
Authoritative Data Verified Data
take this product about 0.15g, precision weighing, add glacial acetic acid 10ml, heat dissolved, add mercury acetate test solution 4ml and crystal violet indicator solution 1 drop, with perchloric acid titration solution (0.1 mol/L) titration to the solution is green, and the result of the titration is corrected with the blank test. Each 1 ml of high gas acid titration solution (0.1 mol/L) corresponds to 20.17mg of C10H15NO. Hc1.
Last Update：2022-01-01 15:34:02
50-98-6 - Category
Authoritative Data Verified Data
B2 adrenergic receptor agonists.
Last Update：2022-01-01 15:34:02
50-98-6 - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:34:02
50-98-6 - Ephedrine hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of ephedrine hydrochloride. The content of ephedrine hydrochloride (C10H15NO • HC1) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take this product, according to the identification of ephedrine hydrochloride (1), (3) test, showed the same reaction.
- 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
- the pH value should be 4.5 to 6.5 (General 0631).
- Related Substances: dilute the product with mobile phase to make a solution containing about 0.9mg of ephedrine hydrochloride per 1 ml as a sample solution; Take appropriate amount with precision, A solution containing about 9UG of ephedrine hydrochloride per 1 ml was prepared by dilution with the mobile phase as a control solution. 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%).
- others should comply with the relevant provisions under injection (General 0102).
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; Phosphate buffer solution (6.8g of potassium dihydrogen phosphate, triethylamine 5ml, phosphoric acid 4ml, add water to 1000ml, dilute phosphoric acid or triethylamine was used to adjust the pH value to 3.0±0.1)-acetonitrile (90:10) as mobile phase; The detection wavelength was 210nm. The number of theoretical plates shall not be less than 3000 calculated as ephedrine hydrochloride peak, and the separation degree between ephedrine hydrochloride peak and adjacent impurity peak shall meet the requirements.
- determination precision: take an appropriate amount of this product, dilute it with mobile phase to make a solution containing about 30ug per lml, and use it as a sample solution. Inject 10ul into the liquid chromatograph with precision and record the chromatogram; another ephedrine hydrochloride reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with ephedrine hydrochloride.
specification
lml:30mg
storage
shading, closed storage
Last Update：2022-01-01 15:34:03
50-98-6 - Ephedrine hydrochloride nasal drops
Authoritative Data Verified Data
This product contains ephedrine hydrochloride (C10H15NO • HCl) should be 90.0% to 110.0% of the label.
trait
This product is a colorless clear liquid.
identification
- take an appropriate amount of this product and show the same reaction according to the tests (1) and (3) under the item of ephedrine 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
- the pH value should be 5.0 to 7.0 (General 0631).
- others should comply with the relevant provisions under nasal preparations (General rule 0106).
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; Phosphate buffer solution (6.8g of potassium dihydrogen phosphate, triethylamine 5ml, phosphoric acid 4ml, add water to 1000ml, dilute phosphoric acid or triethylamine was used to adjust the pH value to 3.0±0.1)-acetonitrile (90:10) as mobile phase; The detection wavelength was 210nm. The number of theoretical plates shall not be less than 3000 calculated as ephedrine hydrochloride peak, and the separation degree between ephedrine hydrochloride peak and adjacent impurity peak shall meet the requirements.
- determination precision: Take appropriate amount of this product, dilute it with mobile phase to make a solution containing about 30ug per lml, and use it as a test solution. Take 10u1 injection of human liquid chromatograph for precision measurement, and record the chromatogram; another ephedrine hydrochloride reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with ephedrine hydrochloride.
specification
1 %
storage
light shielding, closed storage.
Last Update：2022-01-01 15:34:03