Naftifine Hydrochloride Cream
»Naftifine Hydrochloride Cream contains not less than 90.0percent and not more than 110.0percent of Naftifine Hydrochloride (C21H21N·HCl)in a water-miscible base.
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationas obtained in the Assay.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ: meets the requirements.
pHá791ñ: between 4.0and 6.0.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Naftifine Hydrochloride.
Assay preparation— Transfer about 1000mg of Cream,accurately weighed,to a 100-mLvolumetric flask,dissolve in 60mLof methanol,mix vigorously for 2minutes,and dilute with methanol to volume.Heat at 45for 5minutes,and cool to room temperature.
Procedure— Separately inject equal volumes (about 15µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C21H21N·HCl in the portion of Cream taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Naftifine Hydrochloride RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1325
Phone Number:1-301-816-8394