Ceftazidime Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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 90.0 percent and not more than 120.0 percent of the labeled amount of C₂₂H₂₂N₆O₇S₂.

Packaging and storage—Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging. Maintain in the frozen state. Labeling—It meets the requirements for Labeling 〈7〉, Labels and Labeling for Injectable Products. 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 Ceftazidime, Delta-3-Isomer RS 

USP Ceftazidime Pentahydrate RS 

Identication—The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftazidime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay. Bacterial Endotoxins Test 〈85〉 —It contains not more than 0.1 USP Endotoxin Unit per mg of ceftazidime. 

Sterility Tests 〈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 5.0 and 7.5. 

Particulate Matter in Injections 〈788〉: meets the requirements for small-volume injections. 

Assay 

pH 7 Buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under 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 50 mg of ceftazidime, to a 50-mL volumetric ask, dilute with pH 7 buffer to volume, and mix. Transfer 5.0 mL of this solution to a second 50-mL volumetric ask, dilute with water to volume, and mix. 

Procedure—Proceed as directed for Procedure in the Assay under Ceftazidime. Calculate the quantity, in mg, of C₂₂H₂₂N₆O₇S₂ in each mL of the Injection taken by the formula: 

0.5(C/V)(r_U/r_S) 

in which C is the concentration, in µg per mL, of ceftazidime (C₂₂H₂₂N₆O₇S₂) in the Standard preparation;V is the volume, in mL, of Injection taken; and r_U and r_S are the ceftazidime peak responses obtained from the Assay preparation and the Standard preparation, respectively.