Ceftazidime Injection
»Ceftazidime Injection is a sterile isoosmotic solution of Ceftazidime in Water for Injection.It contains one or more suitable buffers and a tonicity-adjusting agent.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of C22H22N6O7S2.
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.
USP Reference standards á11ñ— USP Ceftazidime Pentahydrate RS.USP Delta-3-Ceftazidime Isomer RS.
Identification— The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for ceftazidime,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Pyrogen á151ñ— It meets the requirements,the test dose being a volume of undiluted Injection providing 80mg of ceftazidime per kg.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
pH7buffer ,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—Proceed as directed in the Assayunder Ceftazidime.
Assay preparation— Allow a container of the Injection to thaw,and mix the solution.Transfer an accurately measured volume of the Injection,equivalent to about 50mg of ceftazidime,to a 50-mLvolumetric flask,dilute with pH7bufferto volume,and mix.Transfer 5.0mLof this solution to a second 50-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Ceftazidime.Calculate the quantity,in mg,of C22H22N6O7S2in each mLof the Injection taken by the formula:
0.5(C/V)(rU/rS),
in which Cis the concentration,in µg per mL,of ceftazidime (C22H22N6O7S2)in the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the ceftazidime peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 402
Phone Number:1-301-816-8335