U.S. PHARMACOPEIA

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Tolnaftate Topical Aerosol
» Tolnaftate Topical Aerosol is a suspension of powder in suitable propellants in a pressurized container. The powder contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of tolnaftate (C19H17NOS).
Packaging and storage— Preserve in tight, pressurized containers. Store at controlled room temperature, and avoid exposure to excessive heat.
Identification— It meets the requirements of the Identification test under Tolnaftate Topical Powder.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Pressure Test, Minimum Fill, and Leakage Test under Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers 601.
Assay—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Tolnaftate Topical Powder.
Assay preparation— Remove the actuator button, and replace it with an actuator button that has a small-diameter, stiff polyethylene tube about 15 cm in length fitted tightly into the orifice. Deliver the entire contents of the Topical Aerosol into a conical flask, and heat the flask gently to expel the liquid phase. Cool, mix, and transfer an accurately weighed portion of the powder, equivalent to about 5 mg of tolnaftate, to a screw-capped, 50-mL centrifuge tube. Proceed as directed in the Assay under Tolnaftate Topical Powder, beginning with “Add 25.0 mL of methanol.”
Procedure— Proceed as directed in the Assay under Tolnaftate Topical Powder.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 2175
Pharmacopeial Forum : Volume No. 27(1) Page 1821
Phone Number : 1-301-816-8394