Carteolol Hydrochloride 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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Carteolol Hydrochloride Ophthalmic Solution is a sterile, aqueous, isotonic solution of Carteolol Hydrochloride. It contains a suitable antimicrobial preservative. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₁₆H₂₄N₂O₃· HCl.

Packaging and storage-Preserve in tight containers.

USP REFERENCE STANDARDS (11)-

USP Carteolol Hydrochloride RS

Identification-

A: Prepare a test solution by diluting a suitable volume of Ophthalmic Solution with water, if necessary, to obtain a solution containing about 1 mg of carteolol hydrochloride per mL.. Separately apply 10 µL of the test solution and 10 µL of a Standard solution of USP Carteolol Hydrochloride RS in water containing about 1 mg per mL to the starting line of a thin-layer chromatographic plate (see Chromatography (621)) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry. Line a chromatographic chamber with filter paper, and saturate the paper with a solvent system consisting of a mixture of chloroform, methanol, and ammonium hydroxide (50:20:1). Place the plate in the chamber, and develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and allow to air-dry. Examine the plate under short-wavelength UV light: the R, value of the principal spot in the chromatogram obtained from the test solution corresponds to that in the chromatogram obtained from the Standard solution.

B: The retention time of the carteolol peak in the chromatogram of the Assay preparation obtained as directed in the Assay corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

STERILITY TESTS (71) -It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

PH (791): between 6.0 and 8.0.

Change to read:

Assay-

Buffer, Mobile phase, Standard stock solution, Standard solution, System suitability stock solution, System suitability solution, Chromatographic system, and System suitability (ERR 1-Sep-2020) -Proceed as directed in the Assay under Carteolol Hydrochloride.

Diluent-Prepare a mixture of Buffer and methanol (1:1). (ERR 1-Sep-2020)

Assay preparation-Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 10 mg of carteolol hydrochloride, to a 100-mL volumetric flask, dilute with Diluent to volume, and mix. Pass a portion of this solution through a filter having a porosity of 0.5 µm or finer, discarding the first 2 mL of the filtrate, and use the filtrate as the Assay preparation.

Procedure-Separately inject equal volumes (about 20 µL) of the Standard solution (ERR 1-Sep-2020) and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of C₁₆H₂₄N₂O₃· HCl in each mL of the Ophthalmic Solution taken by the formula:

100(C/V)(r_U/r_S)

in which C is the concentration, in mg per mL, of USP Carteolol Hydrochloride RS in the Standard solution (ERR 1-Sep-2020) V is the volume, in ml, of Ophthalmic Solution taken; and r_Uand r_S are the carteolol peak responses obtained from the Assay preparation and the Standard solution, (ERR 1-Sep-2020) respectively.