Cefotetan Injection
»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 90.0percent and not more than 120.0percent of the labeled amount of cefotetan (C17H17N7O8S4).
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 the 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 in the chromatogram of the Assay preparationcorresponds to that observed in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.17USP Endotoxin Unit per mg of cefotetan.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.0and 6.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder 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 40mg of cefotetan,to a 200-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.[NOTE—Use this solution within 10minutes.]
Procedure— Proceed as directed for Procedurein the Assayunder Cefotetan.Calculate the quantity,in mg,of cefotetan (C17H17N7O8S4)in each mLof the Injection taken by the formula:
0.2(CP/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken to prepare the Assay preparation,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 391
Phone Number:1-301-816-8335