» Cefotetan Injection is a sterile isoosmotic solution of Cefotetan and Sodium Bicarbonate in Water for Injection. It contains one or more buffer substances and a tonicity-adjusting agent. It contains 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 Injections as described under Injections 1. Maintain in the frozen state.
Labeling It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes the conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
USP Reference standards 11
USP Endotoxin RS
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that observed in the chromatogram of the Standard preparation obtained as directed in the Assay.
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.
pH 791: between 4.0 and 6.5.
Particulate matter 788: meets the requirements for small-volume injections.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Cefotetan.
Assay preparation Allow the contents of a container of Injection to thaw, and mix the resultant solution. Transfer an accurately measured volume of this solution, equivalent to about 40 mg of cefotetan, to a 200-mL volumetric flask, dilute with Mobile phase to volume, and mix. [noteUse this solution within 10 minutes. ]
Procedure Proceed as directed for Procedure in the Assay under Cefotetan. Calculate the quantity, in mg, of cefotetan (C17H17N7O8S4) in each mL of the Injection taken by the formula:
0.2(CP / V)(rU / rS)in which V is the volume, in mL, of Injection taken to prepare the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 2560