DEXAMETHASONE BASE
Dexamethasone
CAS: 50-02-2
Molecular Formula: C22H29FO5
DEXAMETHASONE BASE - Names and Identifiers
| Name | Dexamethasone |
| Synonyms | CALONAT DEXAMETHASON Dexamethasone DEXAMETHASONE DEXAMETHASONUM DEXAMETHASONE BASE 9-alpha-fluoro-16-alpha-methylprednisolone (11B,16A)-9-FLUORO-11,17,21-TRIHYDROXY-16-METHYL-PREGNA-1,4-DIENE-3,20-DIONE 1,4-PREGNADIEN-9ALPHA-FLUORO-16ALPHA-METHYL-11BETA, 17ALPHA, 21-TRIOL 3,20-DIONE (11BETA,16ALPHA)-9-FLUORO-11,17,21-TRIHYDROXY-16-METHYLPREGNA-1,4-DIENE-3,20-DIONE 9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16alpha-methylpregn-1,4-diene-3,20-dione (8xi,11beta,16alpha)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 9-alpha-fluoro-11-beta,17-alpha,21-trihydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione |
| CAS | 50-02-2 |
| EINECS | 200-003-9 |
| InChI | InChI=1/C22H29FO5/c1-12-8-16-15-5-4-13-9-14(25)6-7-19(13,2)21(15,23)17(26)10-20(16,3)22(12,28)18(27)11-24/h6-7,9,12,15-17,24,26,28H,4-5,8,10-11H2,1-3H3/t12-,15?,16+,17+,19+,20+,21+,22+/m1/s1 |
| InChIKey | UREBDLICKHMUKA-CXSFZGCWSA-N |
DEXAMETHASONE BASE - Physico-chemical Properties
| Molecular Formula | C22H29FO5 |
| Molar Mass | 392.47 |
| Density | 1.1283 (estimate) |
| Melting Point | 262-264 °C (lit.) |
| Boling Point | 568.2±50.0 °C(Predicted) |
| Specific Rotation(α) | 75 º (c=1, dioxane) |
| Flash Point | 9℃ |
| Water Solubility | 10 mg/100 mL (25 ºC) |
| Solubility | ethanol: 1mg/mL |
| Vapor Presure | 2.81E-15mmHg at 25°C |
| Appearance | White crystalline solid |
| Color | off-white |
| Merck | 14,2943 |
| BRN | 2066651 |
| pKa | 12.13±0.70(Predicted) |
| Storage Condition | 2-8°C |
| Stability | Stable. Combustible. Incompatible with strong oxidizing agents, strong bases, acid anhydrides, acid chlorides. May be light sensitive. |
| Sensitive | Light Sensitive |
| Refractive Index | 76 ° (C=1, Dioxane) |
| MDL | MFCD00064136 |
| Physical and Chemical Properties | Melting point 255-264°C specific rotation 75 ° (c = 1, dioxane) water-soluble 10 mg/100 mL (25°C) |
| Use | Mainly used for anti-inflammatory and anti-allergic, suitable for rheumatoid arthritis and other collagen diseases |
DEXAMETHASONE BASE - Risk and Safety
| Risk Codes | R43 - May cause sensitization by skin contact R40 - Limited evidence of a carcinogenic effect R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R42/43 - May cause sensitization by inhalation and skin contact. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S22 - Do not breathe dust. S16 - Keep away from sources of ignition. |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 2 |
| RTECS | TU3980000 |
| TSCA | Yes |
| HS Code | 29372210 |
| Toxicity | LD50 oral in rat: > 3gm/kg |
DEXAMETHASONE BASE - Standard
Authoritative Data Verified Data
This product is 16a-methyl-11B,17a,21-trihydroxy-9a-fluorogestrol -1, 4-dien-3, 20-dione. Calculated as dry product, containing C22H29F05 should be 97.0% ~ 102.0%.
Last Update：2024-01-02 23:10:35
DEXAMETHASONE BASE - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is slightly soluble in methanol, ethanol, acetone or dioxane, slightly soluble in chloroform, very slightly soluble in ether, almost insoluble in water.
specific rotation
take this product, precision weighing, plus dioxane dissolution and quantitative dilution of about 10 mg per lml solution, according to the law (General 0621), the specific rotation was 72 ° to 80 °.
absorption coefficient
take this product, precision weighing, plus ethanol dissolution and quantitative dilution to make a solution containing about 10ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 240nm, and the absorption coefficient was 380 to 410.
Last Update：2022-01-01 11:43:46
DEXAMETHASONE BASE - Differential diagnosis
Authoritative Data Verified Data
- take about 2mg of this product, add 2ml sulfuric acid, shake to dissolve, within 5 minutes showed light red-brown, add 10ml of water to mix, the color disappeared.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 741).
- This product shows the identification reaction of organic fluoride (General rule 0301).
Last Update：2022-01-01 11:43:47
DEXAMETHASONE BASE - Exam
Authoritative Data Verified Data
Related substances
take this product, precision weigh, add methanol to dissolve and quantitatively dilute to make a solution containing about 0.5mg per 1ml, as a test solution; Take betamethasone reference, precision weigh, add methanol to dissolve and quantitatively dilute to make a solution containing about 0.5mg per 1ml, take 1ml for precision measurement, put it in a 100ml measuring flask, add 1ml of test solution for precision, dilute to the scale with methanol, as a control solution. According to the chromatographic conditions under the content determination item, 20ul of each of the test solution and the control solution are accurately weighed and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2.5 times of the retention time of the main component peak. If the chromatographic peak corresponding to betamethasone in the control solution appears in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content shall not exceed 0.5%; the Peak area of other individual impurities shall not be greater than that of dexamethasone in the control solution (1.0% ) , and the sum of the peak areas of each impurity shall not be greater than 2 times (2.0%) The Peak area of dexamethasone in the control solution. Peaks in the test solution chromatogram that were 0.01 times smaller than the dexamethasone peak area in the control solution were negligible.
loss on drying
take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.2% (General rule 0841).
Last Update：2022-01-01 11:43:47
DEXAMETHASONE BASE - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Acetonitrile-water (28:72) was used as the mobile phase; The detection wavelength was 240nm. 20ul of the control solution under the item of related substances is injected into human liquid chromatograph, and the chromatogram is recorded. The peak sequence is betamethasone peak and dexamethasone peak, and the separation degree should meet the requirements.
assay
take this product, precision weighing, adding methanol to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, as a test solution, take 20ul injection liquid chromatograph for precision measurement, record the chromatogram; Another dexamethasone reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:43:48
DEXAMETHASONE BASE - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 11:43:48
DEXAMETHASONE BASE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:43:48
DEXAMETHASONE BASE - Dexamethasone tablets
Authoritative Data Verified Data
This product contains dexamethasone (C22H29F05) should be labeled the amount of 90.0% to 110.0%.
trait
This product is white tablet.
identification
- 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 10 tablets of this product, grind, add methanol 25ml, shake for 30 minutes to dissolve dexamethasone, filter, the filtrate is dried on a water bath, and the residue shows the identification reaction of organic fluoride (General rule 0301).
examination
- Content uniformity 1 tablet of this product was placed in a mortar, added with 2ml mobile phase, ground, and transferred to a 25ml measuring flask with the mobile phase. The dexamethasone was dissolved by ultrasound and allowed to cool, dilute to scale with mobile phase, shake, filter, and take the filtrate as a test solution. The content of each tablet shall be determined according to the method under the content determination item, and the content of each tablet shall be calculated by the peak area according to the external standard method, and shall comply with the regulations (General rule 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931 method 1), and the hydrochloric acid solution (9-1000) was used as the dissolution medium, and the rotation speed was 75 rpm, operate according to law, after 45 minutes, take the appropriate amount of solution, filter, take the filtrate as the test solution; Take about 10mg of dexamethasone control, put it in a 100ml measuring flask, add 5ml of methanol, shake to dissolve, dilute to scale with dissolution medium, shake well, take an appropriate amount of precision, and dilute with dissolution medium to prepare a solution containing about 0.75ug per 1 ml as a reference solution. The sample solution and the reference solution are respectively 50 u1, and the dissolution amount of each tablet is calculated by the peak area according to the external standard method. The limit is 75% 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
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 1.5mg equivalent to dexamethasone), put it in a 50ml measuring flask, add 4 drops of methanol to wet, add an appropriate amount of mobile phase, shake to dissolve dexamethasone, dilute to scale with mobile phase, shake well, filter, and take the continued filtrate as the test solution. Weigh about 15mg dexamethasone reference, and put it in 50ml measuring flask, after adding 2ml of methanol to dissolve, dilute to the scale with mobile phase, shake well, take 5ml with precision, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a reference solution. According to the method under the dexamethasone content determination, it is obtained.
category
Same as dexamethasone.
specification
0.75mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:43:49
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Product Name: Hexadecadrol; Prednisolone F Visit Supplier Webpage Request for quotationCAS: 50-02-2
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Tel: 0712-8899838
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