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Cefotetan Disodium
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C17H15N7Na2O8S4 619.59

5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[[4-[[(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-, disodium salt, [6R-(6,7)]-.

(6R,7S)-4-[[2-Carboxy-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-7-yl]carbamoyl]-1,3-dithietane-D2,-malonamic acid, disodium salt.

(6R,7S)-7-[4-(Carbamoylcarboxymethylene)-1,3-dithietane-2-carboxamido]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, disodium salt [74356-00-6].
» Cefotetan Disodium contains the equivalent of not less than 830 µg and not more than 970 µg of cefotetan (C17H17N7O8S4) per mg, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
Labeling— Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification—
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
B: It responds to the tests for Sodium 191.
pH 791: between 4.0 and 6.5, in a solution (1 in 10).
Water, Method Ic 921: not more than 1.5%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— Where the label states that Cefotetan Disodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Cefotetan for Injection. Where the label states that Cefotetan Disodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Cefotetan for Injection.
Assay— [NOTE—Protect the Standard preparation, the Resolution solution, and the Assay preparations from light, and use within 2 hours.]
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Cefotetan.
Assay preparation— Transfer about 40 mg of Cefotetan Disodium, accurately weighed, to a 200-mL volumetric flask, add 10 mL of methanol, swirl for several minutes, add 10 mL of acetonitrile, and swirl until dissolved. Dilute with water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Cefotetan. Calculate the quantity, in µg, of cefotetan (C17H17N7O8S4) per mg in the portion of Cefotetan Disodium taken by the formula:
200(CP / M)(rU / rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 425
Phone Number : 1-301-816-8223