A: Transfer a portion of Injection, equivalent to about 100 mg of dicyclomine hydrochloride, to a separator containing 10 mL of water and 1 mL of hydrochloric acid. Shake with 25 mL of ether, and discard the ether layer. Proceed as directed in Identification test A under Dicyclomine Hydrochloride Capsules, beginning with “Extract the aqueous acid solution.”

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

(Official January 1, 2007)

0.02 M Phosphate buffer, pH 7.5, Mobile phase, Diluent, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Dicyclomine Hydrochloride Capsules.

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

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