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.
USP Reference standards 11
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.
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.
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USP35NF30 Page 3684