Tetracaine Hydrochloride Topical 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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Tetracaine Hydrochloride Topical Solution is an aqueous solution of Tetracaine Hydrochloride. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C₁₅H₂₄N₂O₂· HCl. It contains a suitable antimicrobial agent.

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

Labeling—Label it to indicate that the Topical Solution is not to be used if it contains crystals, or if it is cloudy or discolored.

USP Reference standards 〈11〉—

USP Tetracaine Hydrochloride RS

Identification—

Change to read:

A: Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020) —

Solutions: solutions of the Topical Solution employed for measurement of absorbance in the Assay.

B: It responds to the tests for Chloride 〈191〉.

pH 〈791〉: between 4.5 and 6.0.

Assay—

Standard preparation—Prepare as directed in the Assay under Tetracaine Hydrochloride in Dextrose Injection.

Assay preparation—Using an accurately measured volume of Topical Solution, prepare as directed in the Assay under Tetracaine Hydrochloride in Dextrose Injection.

Procedure—Proceed as directed for Procedure in the Assay under Tetracaine Hydrochloride in Dextrose Injection. Calculate the quantity, in mg, of C₁₅H₂₄N₂O₂· HCl in the volume of Topical Solution taken by the formula:

C(A_U /A_S )

in which C is the concentration, in μg per mL, of USP Tetracaine Hydrochloride RS in the Standard preparation, and A_U and A_S are the absorbances of the Assay preparation and the Standard preparation, respectively.