A: Transfer a portion of finely powdered Tablets,equivalent to about 100mg of dicyclomine hydrochloride,to a separator containing 10mLof water and 1mLof hydrochloric acid.Proceed as directed in Identificationtest Aunder Dicyclomine Hydrochloride Capsules,beginning with “Extract the aqueous acid solution.”

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

Medium: 0.01Nhydrochloric acid;500mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Picric acid solutionand Standard solution— Prepare as directed for Dissolutionunder Dicyclomine Hydrochloride Capsules.

Procedure— Proceed as directed for Dissolutionunder Dicyclomine Hydrochloride Capsulesexcept to use 10.0mLof the solution under test and to add 10.0mLof 0.01Nhydrochloric acid to the separator containing the solution under test.

Tolerances— Not less than 75%(Q)of the labeled amount of C19H35NO2·HCl is dissolved in 45minutes.

0.02M Phosphate buffer,pH7.5,Mobile phase,Diluent,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Dicyclomine Hydrochloride Capsules.

Assay preparation— Transfer not fewer than 20Tablets to a tared container,and determine the average Tablet weight.Grind the Tablets to a fine powder using a glass mortar and pestle.Transfer an accurately weighed portion of the powder,equivalent to about 20mg of dicyclomine hydrochloride,to a 50-mLvolumetric flask.Proceed as directed under Dicyclomine Hydrochloride Capsulesbeginning with “Add 2.0mLof water.”

Procedure— Proceed as directed in the Assayunder Dicyclomine Hydrochloride Capsules.Calculate the quantity,in mg,of dicyclomine hydrochloride (C19H35NO2·HCl)in the portion of Tablets taken by the formula: in which Cis the concentration,in mg per mL,of USP Dicyclomine Hydrochloride RSin the Standard preparation;and the other terms are as defined therein.