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.
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.
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.
[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—
0.05 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 (C
16H
17N
5O
7S
2) 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.
