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.
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.
Sterility 71—
It meets the requirements when tested as directed for
Membrane Filtration under
Test for Sterility of the Product to be Examined.
Assay—
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 (C
16H
16N
4O
8S) 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.
