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.
Identification
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.
Assay
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 2129
Pharmacopeial Forum: Volume No. 29(5) Page 1460
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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