Dyclonine Hydrochloride Topical Solution
» Dyclonine Hydrochloride Topical Solution is a sterile, aqueous solution of Dyclonine Hydrochloride. It contains not less than 92.0 percent and not more than 108.0 percent of the labeled amount of C18H27NO2·HCl. It may contain suitable stabilizers and antimicrobial agents.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification To a volume of Topical Solution, equivalent to about 300 mg of dyclonine hydrochloride, add 15 mL of chloroform, shake, and allow the layers to separate. Remove a portion of the chloroform solution, evaporate on a steam bath to dryness, and dry the residue at 105 for 1 hour: the dyclonine hydrochloride so obtained responds to the Identification tests under Dyclonine Hydrochloride.
Sterility 71: meets the requirements.
pH 791: between 3.0 and 5.0.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Dyclonine Hydrochloride Gel.
Assay preparation Transfer an accurately measured volume of Topical Solution, equivalent to about 50 mg of dyclonine hydrochloride, to a 500-mL volumetric flask. Dilute with water to volume, and mix.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C18H27NO2·HCl in each mL of the Topical Solution taken by the formula:
500(C / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Dyclonine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of the Topical Solution taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2998