A: Transfer a portion of Injection,equivalent to about 100mg of dicyclomine hydrochloride,to a separator containing 10mLof water and 1mLof hydrochloric acid.Shake with 25mLof ether,and discard the ether layer.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,Diluent,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Dicyclomine Hydrochloride Capsules.

Assay preparation— Prepare a composite sample of at least 5ampules or 2vials.Transfer an accurately measured volume of the composite sample,equivalent to 20.0mg of dicyclomine hydrochloride,into a 50-mLvolumetric flask,and dilute with Diluentto volume.

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