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 |
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 |
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 |
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%.
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 °.
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.
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.
take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 0.5% (General rule 0831).
not more than 0.2% (General rule 0841).
measured by high performance liquid chromatography (General 0512).
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.
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.
adrenocortical hormone drugs.
light shielding, sealed storage.
This product contains dexamethasone (C22H29F05) should be labeled the amount of 90.0% to 110.0%.
This product is white tablet.
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.
Same as dexamethasone.
0.75mg
light shielding, sealed storage.