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Specifications
| Grade | USP2022 |
| Appearance | White or slightly yellow, friable granules or powder |
| Assay | 96.0%–102.0% |
| Identification A | IR |
| Identification B | Tests for sodium and phosphate |
| Specific rotation | +95°–+102° |
| pH | 7.5–10.5 |
| Water | 6.5% max (anhydrous) |
| Phosphate ions | 1.0% max |
| Selenium | 0.003% max |
| Ordinary Impurities | |
| Impurity A | 0.2% max |
| Impurity B | 1.0% max |
| Impurity D-homo A derivative | 1.0% max |
| Prednisolone | 1.0% max |
| Impurity D-homo B derivative | 1.0% max |
| Prednisone Sodium Phosphate | 0.5% max |
| Impurity C | 0.3% max |
| Impurity D | 0.2% max |
| Impurity E | 0.5% max |
| Impurity F | 0.2% max |
| Any other individual unspecified impurity | 0.1% max |
| Total of all impurities | 3.0% max |
| Residual Solvents | |
| Methanol | 3000 ppm max |
| Acetone | 5000 ppm max |
| Dichloromethane | 600 ppm max |
| Ethyl acetate | 5000 ppm max |
| Tetrafurans | 720 ppm max |
Applications
Prednisolone phosphate sodium is a water-soluble corticosteroid widely used in pharmaceutical, clinical, and research applications. It is commonly applied for the treatment of inflammatory and autoimmune conditions, including arthritis, allergies, asthma, and various dermatological disorders. Its water solubility allows for intravenous, intramuscular, and oral administration, enabling rapid and efficient therapeutic delivery in acute or chronic conditions. In pharmaceutical development, it is used as an active pharmaceutical ingredient for corticosteroid formulations, including tablets, injectables, and topical preparations. In research, prednisolone phosphate sodium is employed to study glucocorticoid receptor signaling, inflammation pathways, and immunosuppressive mechanisms. Its predictable pharmacokinetics and well-characterized effects make it a standard reference compound in clinical and preclinical studies of steroidal therapies.
Benefits
The benefits of prednisolone phosphate sodium arise from its potent anti-inflammatory and immunosuppressive properties, water solubility, and rapid onset of action. Its phosphate ester enhances solubility and bioavailability, enabling fast absorption and distribution in the body, which is particularly advantageous in emergency or hospital settings. The compound effectively suppresses inflammatory mediators, reduces edema, and modulates immune responses, providing relief from acute and chronic inflammatory conditions. Its chemical stability under standard storage conditions ensures reliable potency and long shelf-life, while compatibility with aqueous formulations allows flexible dosing and administration routes. These properties make prednisolone phosphate sodium highly effective for precise, controlled, and reproducible therapeutic outcomes.
Conclusion
Prednisolone phosphate sodium is a versatile and highly effective corticosteroid used in the treatment of inflammation, autoimmune disorders, and allergies, as well as in pharmaceutical research. Its water solubility, rapid bioavailability, and potent anti-inflammatory effects make it suitable for diverse formulations and administration routes. By enabling precise, efficient, and reliable therapeutic intervention, prednisolone phosphate sodium remains a key compound in modern medicine and pharmaceutical applications.
