Cefotetan for Injection
» Cefotetan for Injection contains an amount of Cefotetan Disodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefotetan (C17H17N7O8S4).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution At the time of use, the constituted solution meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.17 USP Endotoxin Unit per mg of cefotetan.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter 788: meets the requirements for small-volume injections.
Add the following:Water, Method Ic 921: not more than 2.8%.3
Change to read:Other requirements It responds to the Identification tests and meets the requirements for pH 3 under Cefotetan Disodium. It also meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay [noteProtect the Standard preparation, the Resolution solution, and the Assay preparations from light, and use within 2 hours.]
Solvent Prepare a mixture of water, methanol, and acetonitrile (90:5:5).
Mobile phase, Solvent, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Cefotetan.
Assay preparation 1 (where the package is represented as being in a single-dose container)Constitute Cefotetan for Injection as directed in the labeling. Withdraw all of the withdrawable contents, and quantitatively dilute with Solvent to obtain a solution containing the equivalent of about 200 µg of cefotetan per mL.
Assay preparation 2 (where the label states the quantity of cefotetan in a given volume of constituted solution)Constitute Cefotetan for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with Solvent to obtain a solution containing the equivalent of about 200 µg of cefotetan per mL.
Procedure Proceed as directed for Procedure in the Assay under Cefotetan. Calculate the quantity, in mg, of cefotetan (C17H17N7O8S4) withdrawn from the container, or in the portion of constituted solution taken by the formula:
(L / D)(CP)(rU / rS)in which L is the labeled quantity, in mg, of cefotetan in the container, or in the volume of constituted solution taken, and D is the concentration, in µg of cefotetan per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively, and the extent of dilution, and the other terms are as defined therein.
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USP32NF27 Page 1847Pharmacopeial Forum: Volume No. 34(1) Page 86