Prednisolone Sodium Phosphate Ophthalmic Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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

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

1 USP Reference standards 〈11〉

USP Prednisolone RS

2 Identification

Change to read:

A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Test specimen: Place 5 mL of the Assay preparation obtained as directed in the Assay, in a glass-stoppered, 100-mL volumetric flask, mix with 5 mL of Alkaline phosphatase solution prepared as directed in the Assay, and add 50 mL of methylene chloride. Insert the stopper, and allow to stand, with occasional gentle inversion (about once every 15 minutes), for 2 hours. Filter the methylene chloride layer through a dry paper, and evaporate 25 mL of the filtrate to dryness.

Standard specimen: Prepare as directed in Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020), using USP Prednisolone RS.

B: Dissolve 65 mg of phenylhydrazine hydrochloride in 100 mL of dilute sulfuric acid (3 in 5), add 5 mL of isopropyl alcohol, and mix. Heat 5 mL of this solution with 1 mL of Assay preparation (obtained as directed in the Assay) at 70° for 2 hours: a yellow color develops.

Sterility Tests 〈71〉: meets the requirements.

pH 〈791〉: between 6.2 and 8.2.

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