Dicyclomine Hydrochloride Oral Solution
» Dicyclomine Hydrochloride Oral Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of dicyclomine hydrochloride (C19H35NO2·HCl).
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Dicyclomine Hydrochloride RS Click to View Structure
Identification—
A: Transfer a portion of the Oral Solution, equivalent to about 100 mg of dicyclomine hydrochloride, to a separator containing 10 mL of water and 1 mL of hydrochloric acid. Extract with two 30-mL portions of ether, and discard the ether. 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.
Assay—
0.02 M Phosphate buffer, pH 7.5, Mobile phase, and Chromatographic system— Prepare as directed in the Assay under Dicyclomine Hydrochloride Capsules.
Diluent— Prepare a mixture of 0.02 M Phosphate buffer, pH 7.5 and acetonitrile (65:35).
Standard preparation— Dissolve an accurately weighed quantity of USP Dicyclomine Hydrochloride RS in Diluent to obtain a solution having a known concentration of about 0.1 mg per mL. [note—This solution is stable for 2 days. ]
Assay preparation— Using a “to contain” pipet, transfer an accurately measured volume of Oral Solution, equivalent to 10.0 mg of dicyclomine hydrochloride, to a 100-mL volumetric flask. Rinse the pipet with several small portions of Diluent, adding the rinsings to the volumetric flask. Dilute with Diluent to volume, and mix.
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 Oral Solution taken by the formula:
100C(rU / rS)
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.
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Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
1-301-816-8251
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USP35–NF30 Page 2887
Pharmacopeial Forum: Volume No. 29(5) Page 1462