Cefoperazone Injection
»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 90.0percent and not more than 120.0percent of the labeled amount of cefoperazone (C25H27N9O8S2).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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.
Identification— The retention time of the major peak for cefoperazone in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.2USP Endotoxin Unit per mg of cefoperazone.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.5and 6.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Cefoperazone Sodium.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with Mobile phaseto obtain a solution containing about 0.16mg of cefoperazone per mL.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Lis the labeled quantity,in mg,of cefoperazone (C25H27N9O8S2),in the volume of Injection taken,Dis 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.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 386
Phone Number:1-301-816-8335