A: Place a quantity of finely powdered Tablets,equivalent to about 50mg of anileridine,in a 250-mLvolumetric flask,add 100mLof water,and heat on a steam bath.Cool,dilute with water to volume,mix,and filter:five mLof the filtrate responds to Identificationtest Cunder Anileridine Hydrochloride.

B: Transfer to a 100-mLvolumetric flask a quantity of finely powdered Tablets,equivalent to about 50mg of anileridine.Add about 30mLof water,and heat on a steam bath.Cool,dilute with water to volume,mix,and filter (Stock solution):the filtrate responds to Identificationtest Bunder Anileridine Hydrochloride,beginning with “Transfer 4.0mLof this solution.”

Medium: 0.01Nhydrochloric acid;900mL.

Apparatus 1: 100rpm.

Time: 45minutes.

Procedure— Determine the amount of anileridine (C22H28N2O2)dissolved,employing the procedure set forth in the Assay,using a filtered portion of the solution under test as the Assay preparationin comparison with a Standard solution having a known concentration of USP Anileridine Hydrochloride RSin the same Medium.

Tolerances— Not less than 65%(Q)of the labeled amount of C22H28N2O2is dissolved in 45minutes.

Standard preparation— Prepare as directed in the Assayunder Anileridine Injection.

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of anileridine,to a 250-mLvolumetric flask.Add 25mLof 1Nhydrochloric acid and 100mLof water,and heat on a water bath.Cool,dilute with water to volume,and mix.Filter the solution,discarding the first 25mLof the filtrate.

Procedure— Proceed as directed for Procedurein the Assayunder Anileridine Injection.Calculate the quantity,in mg,of C22H28N2O2in the portion of Tablets taken by the formula: in which 352.48and 425.40are the molecular weights of anileridine and anileridine hydrochloride,respectively;Cis the concentration,in µg per mL,of USP Anileridine Hydrochloride RSin the Standard preparation;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.