Cefotaxime Injection
»Cefotaxime Injection is a sterile solution of Cefotaxime Sodium in Water for Injection.It contains one or more suitable buffers,and it may contain Dextrose or Sodium Chloride as a tonicity-adjusting agent.It contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of cefotaxime (C16H17N5O7S2).
Packaging and storage— Preserve in single-dose containers,as 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 cefotaxime,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 0.20USP Endotoxin Unit per mg of cefotaxime.
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.
Chromatographic purity— Using the chromatogram of the Assay preparationobtained in the Assay,calculate the percentage of each impurity by the formula:
100ri/(ris+rc),
in which riis the peak area response of a given impurity,risis the sum of all of the impurity peak area responses,and rcis the peak area response for the main cefotaxime peak.[NOTE—Disregard any impurity peak that is less than 0.1%.]Not more than 6.0%of any individual impurity is found,and the sum of all impurities found is not more than 10.0%.
Assay—
0.05M Phosphate buffer,Solution A,Solution B,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Cefotaxime Sodium.
Assay preparation— Allow 1container of Injection to thaw,and mix.Transfer an accurately measured volume of the Injection,equivalent to about 80mg of cefotaxime (C16H17N5O7S2),to a 100-mLvolumetric flask,dilute with Solution Ato volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Cefotaxime Sodium.Calculate the quantity,in mg,of cefotaxime (C16H17N5O7S2)in each mLof the Injection taken by the formula:
0.1(CP/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken,to prepare the Assay preparation,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 389
Phone Number:1-301-816-8335