Dyclonine Hydrochloride Topical Solution
»Dyclonine Hydrochloride Topical Solution is a sterile,aqueous solution of Dyclonine Hydrochloride.It contains not less than 92.0percent and not more than 108.0percent of the labeled amount of C18H27NO2·HCl.It may contain suitable stabilizers and antimicrobial agents.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— To a volume of Topical Solution,equivalent to about 300mg of dyclonine hydrochloride,add 15mLof 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 105for 1hour:the dyclonine hydrochloride so obtained responds to the Identificationtests under Dyclonine Hydrochloride.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 3.0and 5.0.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Dyclonine Hydrochloride Gel.
Assay preparation— Transfer an accurately measured volume of Topical Solution,equivalent to about 50mg of dyclonine hydrochloride,to a 500-mLvolumetric flask.Dilute with water to volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C18H27NO2·HCl in each mLof the Topical Solution taken by the formula:
500(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Dyclonine Hydrochloride RSin the Standard preparation,Vis the volume,in mL,of the Topical Solution taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 706
Phone Number:1-301-816-8379