33125-97-2
etomidate
CAS: 33125-97-2
Molecular Formula: C14H16N2O2
33125-97-2 - Names and Identifiers
| Name | etomidate |
| Synonyms | amidate etomidate ethyl 1-[(1R)-1-phenylethyl]-1H-imidazole-5-carboxylate 1-(1-phenylethyl)-imidazole-5-carboxylic acid ethyl ester |
| CAS | 33125-97-2 |
| EINECS | 251-385-9 |
| InChI | InChI=1/C14H16N2O2/c1-3-18-14(17)13-9-15-10-16(13)11(2)12-7-5-4-6-8-12/h4-11H,3H2,1-2H3/t11-/m1/s1 |
33125-97-2 - Physico-chemical Properties
| Molecular Formula | C14H16N2O2 |
| Molar Mass | 244.289 |
| Density | 1.11g/cm3 |
| Boling Point | 391.5°C at 760 mmHg |
| Flash Point | 190.6°C |
| Vapor Presure | 2.46E-06mmHg at 25°C |
| Refractive Index | 1.561 |
| Use | Short-term intravenous general anesthetic |
33125-97-2 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed |
| Safety Description | S36 - Wear suitable protective clothing. |
33125-97-2 - Standard
Authoritative Data Verified Data
This product is (+)-Ethyl 1-(a-methyl benzyl) imidazole-5-carboxylate. Calculated as dried product, including C14H16N202 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
33125-97-2 - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder.
- This product is highly soluble in ethanol or three gas methane, insoluble in water; Soluble in dilute hydrochloric acid.
melting point
The melting point of this product (General rule 0612 first method) is 66~70°C.
specific rotation
take this product, precision weighing, plus ethanol dissolution and quantitative dilution to make a solution containing 10 mg per lml, according to the law (General 0621), the specific rotation was 67 ° to 72 °.
Last Update：2022-01-01 13:36:14
33125-97-2 - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add dilute hydrochloric acid to dissolve, add a few drops of bismuth potassium iodide solution, which will produce brick red precipitate.
- take this product and add ethanol to make a solution containing 10ug per 1 ml. According to ultraviolet-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 241nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 253).
Last Update：2022-01-01 13:36:14
33125-97-2 - Exam
Authoritative Data Verified Data
clarity and color of the fermentation solution
take 0.25g of this product and add 25ml of anhydrous ethanol to dissolve. The solution should be clear and colorless.
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to prepare a solution containing lmg per lml 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. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-0.062% ammonium acetate solution (60:40) was used as the mobile phase; The detection wavelength was 240nm; the column temperature was 50°C. Take appropriate amount of etomidate reference substance and impurity I reference substance, add mobile phase to dissolve and dilute to prepare a solution containing etomidate lmg and impurity I l0ug per 1 ml, and inject 5ul into the liquid chromatograph, the separation degree of impurity I peak and etomidate peak shall meet the requirements, and the number of theoretical plates shall not be less than 2000 according to etomidate peak. 5 u1 of each of the test solution and the control solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram was recorded to 2 times of the retention time of the main component chromatographic 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 0.3 times (0.3%) of the area of the main peak of the control 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, with phosphorus pentoxide as desiccant, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).
sulfate
take 0.5g of this product, add water to make it 40ml, shake, add dilute hydrochloric acid 2ml, fully shake and dissolve, and check according to law (General rule 0802), not more concentrated (0.02%) than the control solution made of standard potassium sulfate solution.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
precious metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 13:36:15
33125-97-2 - Content determination
Authoritative Data Verified Data
take about 0.2g of this product, precision weighing, add 20ml of glacial acetic acid to dissolve, add 2 drops of naphthol benzyl alcohol indicator solution, and use 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. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 24.43mg of C14H16N2O2.
Last Update：2022-01-01 13:36:16
33125-97-2 - Category
Authoritative Data Verified Data
anesthetics.
Last Update：2022-01-01 13:36:16
33125-97-2 - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update：2022-01-01 13:36:16
33125-97-2 - Etomidate Injection
Authoritative Data Verified Data
This product is a sterile water solution made of etomidate plus 1, 2-propanediol, containing etomidate (C14H16N202) should be 90.0% to 110.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- take 1ml of this product and add a few drops of bismuth potassium iodide solution, which will produce brick red precipitate.
- take the appropriate amount of this product and the reference product of etomidate, respectively diluted with mobile phase to make etomidate 0. The lmg solution is used as the test solution and the reference solution, and the test is carried out according to the method under the item of related substances. 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.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of Nm.
examination
- the pH value should be 5.0 to 6.5 (General 0631).
- appropriate amount of related substances of this product is diluted with mobile phase to prepare a solution containing 1 mg of etomidate per 1ml, which is used as a test solution; 1ml is accurately measured and placed in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the method under the related substances of etomidate, the peak area of a single impurity is not more than the main peak area of the control solution (1.0% ) , and the sum of the peak areas of each impurity is not more than 1.5 times (1.5%) of the main peak area of the control solution..
- 1, 2-propanediol an appropriate amount of N-octanol was taken, dissolved in methanol and diluted to give a solution containing 0.2mg per 1 ml as an internal standard solution. Take lml into a 100ml measuring flask, add internal standard solution to dissolve and dilute to the scale, shake well, then take 5ml into a 50ml measuring flask, dilute to the scale with internal standard solution, shake well, as the test solution; Take the appropriate amount of 1, 2-propanediol reference by precision weighing, A solution containing 0.35mg of 1, 2-propanediol per 1 ml was prepared as a control solution by quantitative dilution with an internal standard solution. Measured by gas chromatography (General 0521). With polyethylene glycol (or polar similar) as the stationary liquid; Temperature program: the initial temperature is 120°C, maintained for 3 minutes, at a rate of 10°C per minute to 230°C, maintained for 5 minutes; the inlet temperature was 220°C; The detector temperature was 250°C. Take appropriate amount of 1, 2-propanediol, 1, 3-propanediol and diethylene glycol, add internal standard solution to dissolve and dilute to make a mixed solution containing 0.35mg per 1 ml, lul was injected into human gas chromatograph, and the chromatogram was recorded. The order of peak emergence is internal standard substance, 1, 2-propanediol, 1, 3-propanediol and diethylene glycol, and the degree of separation between adjacent peaks should be greater than 2.0. The theoretical plate number is not less than 5000 in terms of the 1, 2-propanediol peak. Then the reference solution and the sample solution 1u1 are injected into the gas chromatograph accurately, and the chromatogram is recorded. The peak area is calculated according to the internal standard method, and 1, 2-propanediol should be 315-385mg per 1 ml.
- take 5ml of this product, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, as a test solution; Take an appropriate amount of diethylene glycol reference, A solution containing 25ug of diethylene glycol per 1 ml was prepared as a control solution by quantitative dilution with methanol. According to the chromatographic conditions under the item of 1, 2-propanediol, take 1 u1 of each of the reference solution and the test solution in a precise amount, inject the human gas chromatograph, record the chromatogram, and calculate by peak area according to the external standard method, do not contain more than 0.05% (W/V) diethylene glycol.
- bacterial endotoxin this product, according to the law inspection (General 1143), the amount of endotoxin per 1 mg etomidate should be less than 8.3EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product and quantitatively dilute it with ethanol to make a solution containing 10ug per lml, which is used as a test solution according to ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 241nm; The appropriate amount of etomidate reference substance was accurately weighed, dissolved and diluted with ethanol to prepare a solution containing 10ug per 1 ml, which was determined and calculated by the same method.
category
Same as etomidate.
specification
10ml:20mg
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 13:36:17