Ceftizoxime 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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Ceftizoxime Injection is a sterile solution of Ceftizoxime Sodium in a diluent containing one or more tonicity-adjusting agents in Water for Injection. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ceftizoxime (C₁₃H₁₃N₅O₅S₂). 

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 Ceftizoxime RS 

Identification—The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftizoxime, 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 0.10 USP Endotoxin Unit per mg of ceftizoxime. 

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 5.5 and 8.0. 

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

Assay

pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Ceftizoxime Sodium. 

Assay preparation—Allow 1 container of Injection to thaw, and mix. Transfer an accurately measured volume of the Injection, equivalent to about 40 mg of ceftizoxime, to a 100-mL volumetric flask, dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix. Procedure—Proceed as directed for Procedure in the Assay under Ceftizoxime Sodium. Calculate the quantity, in mg, of ceftizoxime (C₁₃H₁₃N₅O₅S₂) in each mL of the Injection taken by the formula: 

2000(C/V)(R_U/R_S) 

in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.