Prednisolone
prednisolone
CAS: 50-24-8;52438-85-4
Molecular Formula: C21H28O5
Prednisolone - Names and Identifiers
| Name | prednisolone |
| Synonyms | prednisolone HYDRODELTALONE METACORTANDROLONE METACORT AND RALONE DEHYDROHYDROCORTISONE 11,17,21-trihydroxypregna-1,4-diene-3,20-dione 11B,17,21-TRIHYDROXYPREGNA-1,4-DIENE-3,20-DIONE 11BETA 17,21-TRIHYDROXYPREGNA-1,4-DIENE-3,20-DIONE 11-BETA,17-ALPHA,21-HYDROXY-1,4-PREGNADIENE-3,20-DIONE 11BETA,17ALPHA,21-TRIHYDROXYPREGNA-1,4-DIENE-3,20-DIONE 11-beta,17-alpha,21-trihydroxypregna-1,4-diene-3,20-dione (11beta)-11,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl acetate |
| CAS | 50-24-8 52438-85-4 |
| EINECS | 200-021-7 |
| InChI | InChI=1/C23H30O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h6,8,10,16-18,20,26,28H,4-5,7,9,11-12H2,1-3H3/t16-,17-,18-,20+,21-,22-,23-/m0/s1 |
| InChIKey | OIGNJSKKLXVSLS-VWUMJDOOSA-N |
Prednisolone - Physico-chemical Properties
| Molecular Formula | C21H28O5 |
| Molar Mass | 360.45 |
| Density | 1.0963 (rough estimate) |
| Melting Point | 240 °C (dec.) (lit.) |
| Boling Point | 412.46°C (rough estimate) |
| Specific Rotation(α) | D25 +102° (dioxane) |
| Flash Point | 2℃ |
| Water Solubility | 2.225g/L(25 ºC) |
| Solubility | Very slightly soluble in water, soluble in ethanol (96 per cent) and in methanol, sparingly soluble in acetone, slightly soluble in methylene chloride. It shows polymorphism (5.9). |
| Vapor Presure | 7.36E-16mmHg at 25°C |
| Appearance | powder |
| Color | White to Off-White |
| Merck | 14,7721 |
| BRN | 1354103 |
| pKa | 12.46±0.70(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 100 ° (C=1, Dioxane) |
| Physical and Chemical Properties | Crystalline compound. Melting point 225-233 °c (240-241 °c). |
| Use | Suitable for rheumatoid arthritis, rheumatic fever, lupus erythematosus, Dermatomyositis, multiple myeloma, etc |
Prednisolone - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed |
| Toxicity | LD50 oral in mouse: 1680mg/kg |
Prednisolone - Standard
Authoritative Data Verified Data
This product is 11B,17a,21-two light base pregnancy retention -1,4-two dilute -3,20-two ketone, according to the dry product calculation, containing C21H2805 should be 97.0% ~ 102.0%.
Last Update：2024-01-02 23:10:35
Prednisolone - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless; With hygroscopicity.
- This product is dissolved in methanol or ethanol, slightly soluble in acetone or dioxane, slightly soluble in chloroform, and slightly soluble 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 96 ° to 103 °.
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 243nm, and the absorption coefficient was 400 to 430.
Last Update：2022-01-01 13:38:11
Prednisolone - Differential diagnosis
Authoritative Data Verified Data
- Take 10mg of this product, add 1ml of methanol to dissolve, add 1ml of Alkaline copper tartrate test solution, and heat to generate orange-red precipitate.
- take about 2mg of this product, and add 2ml sulfuric acid, and gradually develop deep red, no fluorescence; Add 10ml water, the red color fades, forming gray flocculent precipitate.
- 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 284).
Last Update：2022-01-01 13:38:11
Prednisolone - Exam
Authoritative Data Verified Data
Related substances
take this product, add chloroform-methanol (9:1) dissolved and diluted into a solution containing about 3mg per 1 ml, as a test solution; Take 2ml, in a 100ml measuring flask, dilute to the mark with chloroform-methanol (9:1) and shake to a control solution. According to the thin layer chromatography (General 0502) test, Draw 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with dichloromethane-ether-methanol-water (77:12:6:0.4) as the developing solvent, it was developed, dried, dried at 105 ° C. For 10 minutes, allowed to cool, sprayed with basic tetrazolium blue test solution, and immediately inspected. For the test solution such as impurity spots, not more than 3, the color and the control solution of the main spot comparison, not deeper.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
Last Update：2022-01-01 13:38:12
Prednisolone - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with eighteen alkyl silane bonded silica gel as filler; With methanol-water (65:35) as mobile phase; The detection wavelength was 240nm, the number of theoretical plate according to the calculation of prednisolone peak was not less than 1000, the resolution of prednisolone peak and internal standard substance peak should be greater than 3.5.
preparation of internal standard solution
The norethisterone was taken, dissolved in methanol and diluted to prepare a solution containing about 1.5mg per 1 ml.
assay
take this product, precision weigh, add methanol to dissolve and quantitatively dilute to make a solution containing about 1 mg per 1 ml; Take 5ml of the solution and the internal standard solution for precision measurement, place in 50ml measuring flask, dilute to the scale with methanol, shake well, as a test solution, take 10ul injection human liquid chromatograph, record chromatogram; Take prednisolone reference substance, same method for determination. According to the internal standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:38:13
Prednisolone - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 13:38:13
Prednisolone - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:38:13
Prednisolone - Prednisolone tablets
Authoritative Data Verified Data
This product contains prednisolone (C21H2805) should be 90.0% to 110.0% of the label.
trait
This product is white tablet.
identification
take an appropriate amount of fine powder of this product (about 50mg of prednisolone), add chloroform 30ml, stir to dissolve prednisolone, filter, and evaporate the filtrate on a water bath, the residue showed the same reaction according to the tests of (1) and (2) under the item of prednisolone.
examination
- Content uniformity: Take 1 tablet of this product, put it in mortar, grind it finely, add appropriate amount of ethanol, grind it, and transfer it to 50ml measuring flask with ethanol in portions, shake it thoroughly to dissolve prednisolone, dilute to the scale with ethanol, shake well, filter, Take 5ml of filtrate accurately, place it in another 50ml measuring flask, dilute to the scale with ethanol, shake well, the content shall be determined according to the method under the content determination item, and the calculated content shall comply with the regulations (General rule 0941).
- 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 appropriate amount (about equivalent to prednisolone 20mg), put it in a 100ml measuring flask, add about 75ml ethanol, shake for 30 minutes to dissolve prednisolone, dilute to the scale with ethanol, shake well, filter, Take 5ml of the filtrate accurately, put it in another 100ml measuring flask, dilute to the scale with ethanol, shake well, according to UV-visible spectrophotometry (General rule 0401), absorbance was measured at the wavelength of 243nm, calculated according to the absorption coefficient of C21H2805 415, that is obtained.
category
Same as prednisolone.
specification
5mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:38:14
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