Dicyclomine Hydrochloride Injection
» Dicyclomine Hydrochloride Injection is a sterile, isotonic solution of Dicyclomine Hydrochloride in Water for Injection. It contains not less than 93.0 percent and not more than 107.0 percent of the labeled amount of dicyclomine hydrochloride (C19H35NO2·HCl).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 17.2 USP Endotoxin Units per mg of dicyclomine hydrochloride.
Other requirements It meets the requirements under Injections 1.
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:
50C(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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USP35NF30 Page 2887Pharmacopeial Forum: Volume No. 29(5) Page 1460