Description

Prednisolone Acetate USP/EP

Prednisolone Acetate USP/EP is a high-purity, synthetic corticosteroid used in pharmaceutical formulations for its potent anti-inflammatory and immunosuppressive properties. Compliant with United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards, it is widely used in ophthalmic, topical, and injectable dosage forms to reduce inflammation, swelling, and immune-mediated responses. Prednisolone Acetate
• is a USP/EP-compliant corticosteroid for anti-inflammatory and immunosuppressive use
• is used in ophthalmic suspensions, topical creams, and injectable formulations
• Exhibits strong glucocorticoid activity with predictable pharmacological effects
• Is suitable for acute and chronic inflammatory conditions, allergies, and autoimmune disorders
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA) and technical data
Prednisolone Acetate is chemically designated as 11β,17α,21-Trihydroxy-pregna-1,4-diene-3,20-dione 21-acetate. It appears as a white to off-white crystalline powder that is sparingly soluble in water and readily soluble in alcohols and nonpolar organic solvents. The acetate ester enhances chemical stability and allows for sustained therapeutic activity in ophthalmic and topical formulations.
In pharmaceutical applications, Prednisolone Acetate USP/EP is used in:
• Ophthalmic suspensions for the treatment of ocular inflammation, uveitis, and post-operative swelling
• Topical creams and ointments for dermatologic inflammatory conditions
• Injectable formulations for localized anti-inflammatory therapy
• Combination products with antibiotics or other actives in multi-ingredient therapies
• Compounded formulations requiring precise dosing and controlled anti-inflammatory effect
Prednisolone Acetate USP/EP provides potent suppression of inflammatory mediators, reducing redness, swelling, and tissue damage. Its pharmacokinetic properties allow for controlled, targeted therapy with predictable onset and duration of action.
CarboMer supplies Prednisolone Acetate USP/EP with control over assay, polymorphic form, residual solvents, and microbial content. Each batch meets USP and EP monograph standards for pharmaceutical use.
The material is packaged in sealed, moisture-protective, tamper-evident containers. Available in research, pilot, and commercial-scale quantities. Minimum order quantities (MOQ), lead times, and documentation including CoA and SDS are provided upon request.
Each batch is tested for identity (IR, HPLC), assay (anhydrous basis), melting point, residual solvents, heavy metals, and microbial limits. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.
As with all CarboMer corticosteroid APIs, Prednisolone Acetate USP/EP is supported by formulation guidance, regulatory expertise, and global supply chain reliability to help develop safe, effective, and compliant pharmaceutical products.