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Active Pharmaceuticals

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  • Specifications
  • Product Description
  • Product Usage
  • COA
Product name Prednisolone-21-acetate
Other name Prednisolone acetate
CAS register number 52-21-1
EINECS 200-134-1
Molecular formula C23H30O6
Molecular weight 402.48
Melting point 240°C~244°C
Assay 98%

Prednisolone is a synthetic glucocorticoid, a derivative of cortisol, which is used to treat a variety of inflammatory and auto-immune conditions. It is the active metabolite of the drug prednisone[1] and is used especially in patients with hepatic failure, as these individuals are unable to metabolise prednisone into prednisolone.

Prednisolone is a corticosteroid drug with predominant glucocorticoid and low mineralocorticoid activity, making it useful for the treatment of a wide range of inflammatory and auto-immune conditions such as asthma, uveitis, pyoderma gangrenosum, rheumatoid arthritis, ulcerative colitis, pericarditis, temporal arteritis and Crohn's disease, Bell's palsy, multiple sclerosis, cluster headaches, vasculitis, acute lymphoblastic leukemia and autoimmune hepatitis, systemic lupus erythematosus, Kawasaki disease and dermatomyositis. It is also used for treatment of sarcoidosis, though the mechanism is unknown.

Prednisolone acetate ophthalmic suspension (eye drops) is an adrenocortical steroid product, prepared as a sterile ophthalmic suspension and used to reduce swelling, redness, itching, and allergic reactions affecting the eye.

Prednisolone can also be used as an immunosuppressive drug for organ transplants and in cases of adrenal insufficiency (Addison's disease).

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and, it is presumed, delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation with inflammation.

Product name Prednisolone-21-acetate
Appearance White crystalline powder
Chromatographic purity Any individual impurity not more than 1.0%

Total impurities not more than 2.0%

0.4%

1.2%

Loss on drying Not more than 0.5% 0.3%
Residue on ignition Not more than 0.2% 0.05%
Residual solvents Methanol≤3000ppm

Methylene Chloride≤600ppm

Chloroform≤60ppm

Tetrahydrofuran≤720ppm

385ppm

Not detect out

Not detect out

Not detect out

Assay Between 97.0% and 102.0% 98.8%
Micronixation 90% not more than 10 microns 90% not more than 10

aicrons

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