U.S. PHARMACOPEIA

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Cimetidine in Sodium Chloride Injection
» Cimetidine in Sodium Chloride Injection is a sterile solution of Cimetidine Hydrochloride and Sodium Chloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cimetidine (C10H16N6S) and not less than 95.0 percent and not more than 110.0 percent of the labeled amount of sodium chloride (NaCl).
Packaging and storage— Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass.
Identification—
A: The chromatogram obtained from 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.
B: It responds to the tests for Sodium 191 and for Chloride 191.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mg of cimetidine hydrochloride.
pH 791: between 5.0 and 7.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay for cimetidine—
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 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 cimetidine (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.
Assay for sodium chloride— Dilute an accurately measured volume of Injection quantitatively, and stepwise if necessary, with water to obtain a solution having a concentration of about 0.5 mg of sodium chloride per mL. Titrate with 0.1 N silver nitrate VS, using a silver–silver chloride electrode. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride. From the determined chloride concentration per mL, subtract the quantity, (35.453/252.35)W, to correct for the chloride present as cimetidine hydrochloride, where W is the quantity, in mg per mL, of cimetidine in the Injection, as determined in the Assay for cimetidine. Multiply the corrected value by 1.648 to obtain the quantity, in mg per mL, of sodium chloride in the volume of Injection taken.
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