A: Transfer a quantity of powdered Tablets,equivalent to about 50mg of meperidine hydrochloride,to a separator,add 10mLof water,and shake.Add 5mLof saturated sodium chloride solution and 1mLof sodium hydroxide solution (1in 25).Extract with three 20-mLportions of chloroform,filtering the extracts through cotton overlaid with anhydrous sodium sulfate.Evaporate the chloroform on a steam bath,and dissolve the residue in 4mLof carbon disulfide.In a second separator,prepare a similar solution,using 50mg of USP Meperidine Hydrochloride RS.Proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,beginning with “Determine the absorption spectra.”

B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that obtained in the Standard preparationobtained in the Assay.

Medium: water;500mL.

Apparatus 1: 100rpm.

Time: 45minutes.

Procedure— Determine the amount of C15H21NO2·HCl dissolved employing the procedure set forth in the Assay,using filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Meperidine Hydrochloride RSin the same Medium.

Tolerances— Not less than 75%(Q)of the labeled amount of C15H21NO2·HCl is dissolved in 45minutes.

Buffer solution ,Mobile phase,Chromatographic system,and Standard preparation—Proceed as directed in the Assayunder Meperidine Hydrochloride.

Assay preparation— Weigh and grind not less than 20Tablets to a fine powder.Transfer an accurately weighed portion of the powder,equivalent to about 60mg of meperidine hydrochloride,to a 100-mLvolumetric flask,add about 70mLof Mobile phase,and sonicate for 10minutes with occasional shaking.Shake by mechanical means for about 30minutes,dilute with Mobile phaseto volume,mix,and filter.Transfer 5.0mLof the filtered solution to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Meperidine Hydrochloride.Calculate the quantity,in mg,of C15H21NO2·HCl in the portion of Tablets taken by the formula: in which Cis the concentration,in mg per mL,of USP Meperidine Hydrochloride RSin the Standard preparation,and rUand rSare the meperidine peak responses obtained from the Assay preparationand the Standard preparation,respectively.