» Cefuroxime Injection is a sterile isoosmotic solution of Cefuroxime Sodium 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 cefuroxime (C16H16N4O8S).
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 cefuroxime, 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 cefuroxime.
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 5.0 and 7.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements for Uniformity of Dosage Units 905.
pH 3.4 Acetate buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Cefuroxime Sodium.
Assay preparation Allow a container of Injection to thaw, and mix the solution. Transfer an accurately measured volume of the Injection, equivalent to about 50 mg of cefuroxime, to a 50-mL volumetric flask, dilute with water to volume, and mix. Immediately transfer 5.0 mL of this solution to a second 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Cefuroxime Sodium. Calculate the quantity, in mg, of cefuroxime (C16H16N4O8S) in each mL of the Injection taken by the formula:
1000(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 2581