Lidocaine Hydrochloride Topical Solution, chemical structure, molecular formula, Reference Standards

Lidocaine Hydrochloride Topical Solution

»Lidocaine Hydrochloride Topical Solution contains not less than 95.0percent and not more than 105.0percent of the labeled amount of lidocaine hydrochloride (C14H22N2O·HCl).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Lidocaine RS.

Identification— Aportion of Topical Solution equivalent to about 200mg of lidocaine hydrochloride responds to the Identificationtest under Lidocaine Hydrochloride Injection.

pHá791ñ: between 5.0and 7.0.

Assay—

Mobile phase,Standard preparation,andResolution preparation— Prepare as directed in the Assay for lidocaine hydrochlorideunder Lidocaine and Epinephrine Injection.

Assay preparation— Transfer an accurately measured volume of Topical Solution,equivalent to about 100mg of lidocaine hydrochloride,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assay for lidocaine hydrochlorideunder Lidocaine and Epinephrine Injection.Calculate the quantity,in mg,of lidocaine hydrochloride (C14H22N2O·HCl)in each mLof the Topical Solution taken by the formula:

(270.80/234.34)(50)(C/V)(rU/rS),

in which Vis the volume,in mL,of Topical Solution taken,and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1131

Phone Number:1-301-816-8379