» 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 in Containers for Injections as described under Injections 1. Maintain in the frozen state.
Labeling It meets the requirements for Labeling under Injections 1. 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 Endotoxin 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 85 It contains not more than 0.10 USP Endotoxin Unit per mg of ceftizoxime.
Sterility 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 788: meets the requirements for small-volume injections.
pH 3.6 Buffer , pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic systemPrepare 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)(RU / RS)in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
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USP35NF30 Page 2575