A: Transfer a portion of the Syrup,equivalent to about 100mg of dicyclomine hydrochloride,to a separator containing 10mLof water and 1mLof hydrochloric acid.Extract with two 30-mLportions of ether,and discard the ether.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.

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

Diluent— Prepare a mixture of 0.02M Phosphate buffer,pH7.5and acetonitrile (65:35).

Standard preparation— Dissolve an accurately weighed quantity of USP Dicyclomine Hydrochloride RSin Diluentto obtain a solution having a known concentration of about 0.1mg per mL.[NOTE—This solution is stable for 2days.]

Assay preparation— Using a “to contain”pipet,transfer an accurately measured volume of Syrup,equivalent to 10.0mg of dicyclomine hydrochloride,to a 100-mLvolumetric flask.Rinse the pipet with several small portions of Diluent,adding the rinsings to the volumetric flask.Dilute with Diluentto volume,and mix.

Procedure— Proceed as directed in the Assayunder Dicyclomine Hydrochloride Capsules.Calculate the quantity,in mg,of dicyclomine hydrochloride (C19H35NO2·HCl)in the portion of Syrup 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.