Cetylpyridinium Chloride Topical Solution
» Cetylpyridinium Chloride Topical Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C21H38ClN·H2O.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Cetylpyridinium Chloride RS Click to View Structure
Identification—
A: Dilute a volume of Topical Solution to a concentration of about 40 µg of cetylpyridinium chloride per mL: the UV absorption 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 500 mg of cetylpyridinium chloride, on a steam bath to one-half of its original volume: the resulting solution meets the requirements of Identification test C under Cetylpyridinium Chloride.
Assay— Transfer a volume of Topical Solution, equivalent to about 150 mg of cetylpyridinium chloride, to a glass-stoppered, 500-mL graduated cylinder, and proceed as directed in the Assay under Cetylpyridinium Chloride, beginning with “Add 10 mL of chloroform.” Each mL of 0.02 M sodium tetraphenylboron is equivalent to 7.160 mg of C21H38ClN·H2O.
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Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientific Liaison
1-301-816-8394
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 2603