Ceftizoxime for 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 for Injection contains an amount of Ceftizoxime Sodium equivalent to 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, Packaging for constitution. USP Reference standards 〈11〉— 

USP Ceftizoxime RS 

Constituted solution—At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Specic Tests, Completeness and clarity of solutions. 

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. 

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

Other requirements—It responds to the Identification tests and meets the requirements for Crystallinity, pH, and Water under Ceftizoxime Sodium. It meets also the requirements for Uniformity of Dosage Units 〈905〉 and for Labeling 〈7〉, Labels and Labeling for Injectable Products.

Assay

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

Standard preparation—Dissolve a suitable quantity of USP Ceftizoxime RS, accurately weighed, in pH 7.0 Buffer to obtain a solution having a known concentration of about 1 mg of ceftizoxime (C₁₃H₁₃N₅O₅S₂) per mL. Transfer 2.0 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. This Standard preparation contains about 0.02 mg of ceftizoxime per mL. 

Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Ceftizoxime for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with pH 7.0 Buffer to obtain a solution containing about 1 mg of ceftizoxime per mL. Transfer 2.0 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. 

Assay preparation 2 (where the label states the quantity of ceftizoxime in a given volume of constituted solution)—Constitute Ceftizoxime for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specied in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with pH 7.0 Buffer to obtain a solution containing about 1 mg of ceftizoxime per mL. Transfer 2.0 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 with Ceftizoxime for Injection as directed for Procedure in the Assay under Ceftizoxime Sodium. Calculate the quantity, in mg, of ceftizoxime (C₁₃H₁₃N₅O₅S₂) withdrawn from the container, or in the portion of constituted solution taken by the formula:

(L/D)(C)(R_U/R_S) 

in which L is the labeled quantity, in mg of ceftizoxime (C₁₃H₁₃N₅O₅S₂), in the container, or in the volume of constituted solution taken, and D is the concentration, in mg of ceftizoxime (C₁₃H₁₃N₅O₅S₂) per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively; and the extent of dilution, C is the concentration, in mg of ceftizoxime (C₁₃H₁₃N₅O₅S₂) per mL, of the Standard preparation; and R_U and R_S are the peak response ratios of the ceftizoxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.