» 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 90.0 percent and not more than 110.0 percent of the labeled amount of cefotaxime (C16H17N5O7S2).
Packaging and storage Preserve in single-dose containers, 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 cefotaxime, 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 0.20 USP Endotoxin Unit per mg of cefotaxime.
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.
Chromatographic purity Using the chromatogram of the Assay preparation obtained in the Assay, calculate the percentage of each impurity by the formula:
100ri / (ris + rc)in which ri is the peak area response of a given impurity; ris is the sum of all of the impurity peak area responses; and rc is the peak area response for the main cefotaxime peak. [noteDisregard 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%.
0.05 M Phosphate buffer, Solution A, Solution B, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Cefotaxime Sodium.
Assay preparation Allow 1 container of Injection to thaw, and mix. Transfer an accurately measured volume of the Injection, equivalent to about 80 mg of cefotaxime (C16H17N5O7S2), to a 100-mL volumetric flask, dilute with Solution A to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Cefotaxime Sodium. Calculate the quantity, in mg, of cefotaxime (C16H17N5O7S2) in each mL of the Injection taken by the formula:
0.1(CP / V)(rU / rS)in which V is the volume, in mL, of Injection taken, to prepare the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 2558