Cefuroxime Injection
»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 90.0percent and not more than 120.0percent of the labeled amount of cefuroxime (C16H16N4O8S).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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.
Identification— The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for cefuroxime,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial Endotoxins á85ñ— It contains not more than 0.10USP Endotoxin Unit per mg of cefuroxime.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñ.
Assay—
pH3.4Acetate buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in theAssayunder 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 50mg of cefuroxime,to a 50-mLvolumetric flask,dilute with water to volume,and mix.Immediately transfer 5.0mLof this solution to a second 100-mLvolumetric flask,add 20.0mLof Internal standard solution,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Cefuroxime Sodium.Calculate the quantity,in mg,of cefuroxime (C16H16N4O8S)in each mLof the Injection taken by the formula:
1000(C/V)(RU/RS),
in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 409
Phone Number:1-301-816-8335