A: It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ.

B: It responds to Identificationtest Bunder Prilocaine Hydrochloride.

Mobile phase— Mix 50mLof glacial acetic acid and 930mLof water,and adjust with 1Nsodium hydroxide to a pHof 3.40.Mix about 4volumes of this solution with 1volume of acetonitrile,such that the retention time of prilocaine is about 4to 6minutes.Filter through a membrane filter (1µm or finer porosity),and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).

Standard preparation— Dissolve an accurately weighed quantity of USP Prilocaine Hydrochloride RSquantitatively in Mobile phaseto obtain a solution having a known concentration of about 4mg per mL.

Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 200mg of prilocaine hydrochloride,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

Resolution preparation— Prepare a solution of procainamide hydrochloride in Mobile phasecontaining about 900µg per mL.Mix 2mLof this solution and 20mLof Standard preparation.

Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm ×30-cm column that contains packing L1,and is operated at a temperature between 20and 25maintained at ±1.0of the selected temperature.The flow rate is about 1.5mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 1.5%.Chromatograph about 10µLof the Resolution preparation,and record the peak responses as directed for Procedure:the resolution,R,between the prilocaine and procainamide peaks is not less than 2.0.

Procedure— [NOTE—Use peak areas where peak responses are indicated.]Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the liquid chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C13H20N2O·HCl in each mLof the Injection taken by the formula: in which Cis the concentration,in mg per mL,of USP Prilocaine Hydrochloride RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.