U.S. PHARMACOPEIA

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Tetracaine Hydrochloride Topical Solution
» 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.
Identification—
A:Ultraviolet Absorption 197U—
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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(AU / AS),
in which C is the concentration, in µg per mL, of USP Tetracaine Hydrochloride RS in the Standard preparation, and AU and AS are the absorbances of the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2096
Phone Number : 1-301-816-8143