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.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2222
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.