U.S. PHARMACOPEIA

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Cimetidine Injection
» Cimetidine Injection is a sterile solution of Cimetidine Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C10H16N6S.
Packaging and storage— Preserve in single-dose or multiple-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass.
Identification— The chromatogram of the Assay preparation exhibits a major peak for cimetidine, the retention time of which corresponds to that of the cimetidine peak in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mg of cimetidine hydrochloride.
pH 791: between 3.8 and 6.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Cimetidine Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 2 mg of cimetidine, to a 200-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the quantity, in mg, of C10H16N6S in each mL of the Injection taken by the formula:
200(252.34/288.81)(C/V)(rU / rS),
in which 252.34 and 288.81 are the molecular weights of cimetidine and cimetidine hydrochloride, respectively; C is the concentration, in mg per mL, of USP Cimetidine Hydrochloride RS in the Standard preparation; V is the volume of Injection taken; and rU and rS are the cimetidine peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 514
Phone Number : 1-301-816-8251