Hydrocortisone is the main hormone of the adrenal cortex. It is a short-acting glucocorticoid and also has a weak mineralocorticoid effect.
It is involved in many physiological processes of the human body, including anti-inflammatory, anti-allergic, anti-shock, and immune regulation.
It has short-acting characteristics, direct activity and multiple dosage forms, and plays an important role in the field of emergency and critical care and skin disease treatment.
Items | Standard | Results |
Description | White to practically white, odorless,crystalline powder. | white crystalline powder |
Solubility | Sparingly soluble in acetone and in alcohol,slightly soluble in chloroform; very slightly soluble in water and in ether. | complies |
Identification | A.IR B.UV | |
Specific rotaion | +150°-156° | 153.6° |
Loss on drying | ≤1.0% | 0.03% |
Residual ignition | ≤0.5% | 0.03% |
Total impurities | ≤2.0% | 0.59% |
Any max individual impurity | ≤0.5% | 0.10% |
Particle size | 90%≤20um | |
Residual Solvent | Methanol ≤3000ppm | 97 ppm |
Dichloromethane ≤600ppm | 62 ppm | |
Acetone≤5000ppm | ND | |
Tetrahydrofuran≤720ppm | ND | |
Assay(HPLC) | 97%-102% | 100.10% |
Conclusion | The test product complies with the requirements of USP43. |
Hydrocortisone powder is an active pharmaceutical ingredient (API) and is commonly used in pharmaceutical formulations.
Form | Usage |
---|---|
Topical (cream) | For skin inflammation |
Oral tablet | For systemic inflammation |
Injection | For emergencies or adrenal crisis |
Rectal (suppository/foam) | For hemorrhoids, proctitis |
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