Lidocaine Hydrochloride Oral Topical Solution
» Lidocaine Hydrochloride Oral 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). It contains a suitable flavor and/or sweetening agent.
Packaging and storage—
Preserve in tight containers.
Identification—
Place in a separator a volume of Oral Topical Solution, equivalent to about 300 mg of lidocaine hydrochloride, and extract with four 15-mL portions of chloroform, discarding the chloroform extracts. Add 2 mL of 2 N sodium hydroxide to the aqueous solution remaining in the separator, and extract with four 15-mL portions of chloroform. Combine the chloroform extracts, and evaporate with the aid of a current of warm air to dryness. Dissolve the crystals so obtained in solvent hexane, evaporate with the aid of warm air, and dry the residue in vacuum over silica gel for 24 hours: the residue so obtained responds to Identification test A under Lidocaine.
pH 
791
:
between 5.0 and 7.0.
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 Oral 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 Oral Topical Solution taken by the formula:
(270.80 / 234.34)(50)(C / V)(rU / rS)
in which V is the volume, in mL, of Oral Topical Solution taken; and the other terms are as defined therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| 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 columns text is not derived from, and not part of, USP 32 or NF 27.