dexamethasone-21-acetate
dexamethasone-21-acetate
CAS: 1177-87-3
Molecular Formula: C24H31FO6
dexamethasone-21-acetate - Names and Identifiers
dexamethasone-21-acetate - Physico-chemical Properties
| Molecular Formula | C24H31FO6 |
| Molar Mass | 434.5 |
| Density | 1.1517 (estimate) |
| Melting Point | 238-240°C(lit.) |
| Boling Point | 579.4±50.0 °C(Predicted) |
| Specific Rotation(α) | D25 +73° (chloroform) (Arth, 1958); D +77.6° (Oliveto) |
| Flash Point | 304.2°C |
| Water Solubility | 13mg/L(25 ºC) |
| Solubility | Easily soluble in acetone, dissolved in methanol or ethanol, slightly soluble in ethanol or chloroform, slightly soluble in ether, insoluble in water |
| Vapor Presure | 7.75E-16mmHg at 25°C |
| Appearance | White or nearly white crystalline powder |
| Color | White |
| Merck | 2943 |
| BRN | 2342608 |
| pKa | 12.08±0.70(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 87 ° (C=1, Dioxane) |
| MDL | MFCD00027407 |
| Physical and Chemical Properties | White or off-white crystalline powder, odorless and slightly bitter in taste. The product is soluble in acetone, dissolved in methanol or ethanol, slightly soluble in ethanol or chloroform, very slightly soluble in ether, insoluble in water. Melting point 215-227 °c. |
| Use | For anti-inflammatory and anti-allergic, suitable for rheumatoid arthritis and other collagen diseases |
dexamethasone-21-acetate - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 43 - May cause sensitization by skin contact |
| Safety Description | 36/37 - Wear suitable protective clothing and gloves. |
| WGK Germany | 3 |
| RTECS | TU4050000 |
| TSCA | Yes |
| HS Code | 29372290 |
dexamethasone-21-acetate - Compound dexamethasone acetate cream
Authoritative Data Verified Data
This product contains dexamethasone acetate (C24H31F06), camphor (C10H16O) and menthol (C10H200) should be 90.0% to 110.0% of the label amount.
prescription
dexamethasone acetate 0.75g
Camphor 10g
Menthol 10G
nipagin lg
Appropriate amount of matrix
Appropriate amount of purified water
Made up to 1000g
trait
This product is a white cream; There is a specific aroma of camphor.
identification
- in the chromatogram recorded under the content determination of dexamethasone acetate, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
- in the chromatogram recorded under the content determination of camphor and menthol, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
should comply with the relevant provisions under Cream (General rule 0109).
Content determination
- dexamethasone acetate was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (70:30) as mobile phase; The detection wavelength was 240nm. The number of theoretical plates shall not be less than 2000 based on the calculation of dexamethasone acetate peak, and the separation degree of dexamethasone acetate peak, internal standard substance peak and adjacent impurity peak shall meet the requirements.
- preparation of internal standard solution methyltestosterone was taken, dissolved in methanol and diluted to prepare a solution containing about 0.20mg per 1 ml.
- determination method: take an appropriate amount of this product (about 1.35mg equivalent to dexamethasone acetate) and set it in a beaker. Add 5ml of internal standard solution and 20ml of methanol, dissolve dexamethasone acetate by heating and stirring in an 80°C water bath, cool in an ice bath, filter after the matrix solidifies, extract the matrix twice with methanol, 10ml each time, filter, combine the three filtrates in the same 50ml measuring flask, dilute to the scale with methanol, shake well, cool in an ice bath for more than 2 hours, take them out, quickly filter them, and take the continued filtrate as the test solution, inject 20ul into the liquid chromatograph, record the chromatogram; Accurately weigh about 13mg of dexamethasone acetate reference substance, put it in 50ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, 5ml of the solution and 5ml of the internal standard solution were accurately measured, placed in a 50ml measuring flask, diluted to the scale with methanol, and shaken, and measured by the same method. According to the internal standard method to calculate the peak area, that is.
- camphor and menthol were measured by gas chromatography (General 0521).
- chromatographic conditions and system suitability test with 6% cyanopropylphenyl-94% dimethylpolysiloxane as stationary phase (DB-624 or capillary column with equivalent performance) and column temperature of 140°C; the number of theoretical plates shall not be less than 5000 based on menthol peak, and the separation degree between menthol peak and internal standard substance peak shall be greater than 4.0.
- preparation of internal standard solution an appropriate amount of naphthalene was taken and diluted with absolute ethanol to prepare a solution containing about 3.2mg per 1 ml.
- determination method: take an appropriate amount of this product (about 20mg of camphor), weigh it accurately, put it in a 50ml measuring flask, add 5ml of internal standard solution accurately, and add an appropriate amount of anhydrous ethanol, heat the camphor and menthol in a water bath at 80°C to dissolve, cool, dilute to the scale with absolute ethanol, shake well, cool in an ice bath for 1 hour, remove and filter with a 0.45um filter, take the filtrate as the test solution, inject 1u1 into the gas chromatograph, record the chromatogram; Take 20mg of camphor and menthol respectively, weigh them accurately, put them in 50ml measuring flask, precision Plus internal standard solution 5ml, plus anhydrous ethanol dissolved and diluted to the scale, shake, the same method, according to the internal standard method to calculate the peak area, that is.
category
adrenocortical hormone drugs.
specification
(l)10g:7.5mg (2)20g:15mg
storage
sealed and stored in a cool place.
Last Update：2022-01-01 13:43:53
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View History
dexamethasone-21-acetate
Benzeneacetic acid, 2-(4-chlorophenoxy)-
Carphedon
乙基芥子油
Pregna-4,9(11)-diene-7,21-dicarboxylic acid, 17-hydroxy-3-oxo-, g-lactone, methyl ester, (7a,17a)-
马桑内酯
氟乙酰
Benzoicacid,3,5-bis(1,1-dimethylethyl)-4-hydroxy-,hexadecylester
辛基酰苯
4-Trifluoromethylmercaptophenol
Benzeneacetic acid, 2-(4-chlorophenoxy)-
Carphedon
乙基芥子油
Pregna-4,9(11)-diene-7,21-dicarboxylic acid, 17-hydroxy-3-oxo-, g-lactone, methyl ester, (7a,17a)-
马桑内酯
氟乙酰
Benzoicacid,3,5-bis(1,1-dimethylethyl)-4-hydroxy-,hexadecylester
辛基酰苯
4-Trifluoromethylmercaptophenol