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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.
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 tests A, B, and C under Cetylpyridinium Chloride.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 459
Phone Number : 1-301-816-8394