Cetylpyridinium Chloride Topical Solution
»Cetylpyridinium Chloride Topical Solution contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C21H38ClN·H2O.
Packaging and storage— Preserve in tight containers.
Identification—
A: Dilute a volume of Topical Solution to a concentration of about 40µg of cetylpyridinium chloride per mL:the UVabsorption spectrum of the resulting solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Cetylpyridinium Chloride RS,concomitantly measured.
B: Evaporate a volume of Topical Solution,equivalent to about 500mg of cetylpyridinium chloride,on a steam bath to one-half of its original volume:the resulting solution meets the requirements of Identificationtests A,B,and Cunder Cetylpyridinium Chloride.
Assay— Transfer a volume of Topical Solution,equivalent to about 150mg of cetylpyridinium chloride,to a glass-stoppered,500-mLgraduated cylinder,and proceed as directed in the Assayunder Cetylpyridinium Chloride,beginning with “Add 10mLof chloroform.”Each mLof 0.02Msodium tetraphenylboron is equivalent to 7.160mg of C21H38ClN·H2O.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 424
Phone Number:1-301-816-8394
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