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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 90.0percent and not more than 110.0percent 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 Identificationtest under Tolnaftate Topical Powder.
Other requirements—
It meets the requirements for Pressure Test,Minimum Fill,and Leakage Testunder Aerosols,Nasal Sprays,Metered-Dose Inhalers,and Dry Powder Inhalers á601ñ.
Assay—
Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system—
Proceed as directed in the Assayunder 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 15cm 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 5mg of tolnaftate,to a screw-capped,50-mLcentrifuge tube.Proceed as directed in the Assayunder Tolnaftate Topical Powder,beginning with “Add 25.0mLof methanol.”
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1951
Pharmacopeial Forum:Volume No.27(1)Page 1821
Phone Number:1-301-816-8394
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