Dyclonine Hydrochloride Topical Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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)-
USP Dycionine Hedrachionnde RE
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 TESTS (71): meets the requirements.
PH (791): between 3.0 and 5.0.
Assay—
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 pl.) 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 CHNO, HCI 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.
