Hormone
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Prednisolone
Chemical Name | ：Prednisolone |
Category | ：Steroid Hormone |
Specification | ：BP |
HS Code | ：2937.2100.00 |
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Structure Formula | ： |
CAS Number | ：50-24-8 |
Molecular Formula | ：C21H28O5 |
Usage | ：Mainly used for allergic and autoimmune inflammatory disease, collagen disorders, such as rheumatism, rheumatoid arthritis, lupus erythematosus, serious bronchus asthma, nephrotic syndrome, thrombocytopenic purpura, granulocytopenia syndrome, acute lymphoid leukemia, all kinds of adrenocortical insufficiency syndrome, exfoliative dermatitis, pemphigus, neurodermatitis and eczema. |
Items | Standard |
|---|---|
Appearance | A white or almost white, crystalline powder |
Solubility | Should meet the requirement |
Identification | IR:Conforms to the CRS spectrum TLC:The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution |
Specifi rotation | +96º~+102º(Dioxane) |
Loss on drying | ≤1.0% Any individual impurity≤1.0% |
Chromatographic purity(by HPLC) | ≥0.5% impurity not more than one |
Assay(by UV) | Total impurities≤2.0% Contains 97.0% to 103.0% of C21H28O5 Calculated on anhydrous basis. |
Residual solvents | Methanol≤3000 Methylene≤600 Ethanol≤5000 |
The available documents are:
Chinese GMP
CEP
DMF/CTD format
The available registered countries are:
Algeria
Spain
Australia