Prednisolone Sodium Phosphate Ophthalmic Solution, chemical structure, molecular formula, Reference Standards

Prednisolone Sodium Phosphate Ophthalmic Solution

»Prednisolone Sodium Phosphate Ophthalmic Solution is a sterile solution of Prednisolone Sodium Phosphate in a buffered,aqueous medium.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of prednisolone phosphate (C21H29O8P),present as the disodium salt.

Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Prednisolone RS.

Identification— It responds to Identificationtest Aunder Prednisolone Sodium Phosphateand to Identificationtest Aunder Prednisolone Sodium Phosphate Injection.

Sterility á71ñ: meets the requirements.

pHá791ñ: between 6.2and 8.2.

Assay— Proceed with Ophthalmic Solution as directed in the Assayunder Prednisolone Sodium Phosphate Injection.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1613

Phone Number:1-301-816-8139