Lidocaine Hydrochloride Topical Solution
» Lidocaine Hydrochloride Topical Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of lidocaine hydrochloride (C14H22N2O·HCl).
Packaging and storage— Preserve in tight containers.
Identification— A portion of Topical Solution equivalent to about 200 mg of lidocaine hydrochloride responds to the Identification test under Lidocaine Hydrochloride Injection.
pH 791: between 5.0 and 7.0.
Assay—
Mobile phase, Standard preparation, and Resolution preparation— Prepare as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection.
Assay preparation— Transfer an accurately measured volume of Topical Solution, equivalent to about 100 mg of lidocaine hydrochloride, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection. Calculate the quantity, in mg, of lidocaine hydrochloride (C14H22N2O·HCl) in each mL of the Topical Solution taken by the formula:
(270.80 / 234.34)(50)(C / V)(rU / rS)
in which V is the volume, in mL, of Topical Solution taken; and the other terms are as defined therein.
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
1-301-816-8143		 (MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2783
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.