» Cefoperazone Injection is a sterile solution of Cefoperazone Sodium and a suitable osmolality adjusting substance in Water for Injection. It may contain a suitable buffer. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefoperazone (C25H27N9O8S2).
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 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 for cefoperazone in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 0.2 USP Endotoxin Unit per mg of cefoperazone.
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 4.5 and 6.5.
Particulate matter 788: meets the requirements for small-volume injections.
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Cefoperazone Sodium.
Assay preparation Quantitatively dilute an accurately measured volume of Injection with Mobile phase to obtain a solution containing about 0.16 mg of cefoperazone per mL.
Procedure Proceed as directed for Procedure in the Assay under Cefoperazone Sodium. Calculate the quantity, in mg, of cefoperazone (C25H27N9O8S2), in the volume of Injection taken by the formula:
(L / D)(C)(rU / rS)in which L is the labeled quantity, in mg, of cefoperazone (C25H27N9O8S2), in the volume of Injection taken; D is the concentration, in mg of cefoperazone (C25H27N9O8S2) per mL, of the Assay preparation, based on the labeled quantity in the portion of Injection taken and the extent of dilution; and the other terms are as defined therein.
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USP35NF30 Page 2554