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 ceftizoxime, the retention time of which corresponds to that exhibited in the chromatogram of the
Standard preparation obtained as directed in the
Assay.
Assay—
pH 3.6 Buffer
,
pH 7.0 Buffer,
Mobile phase,
Internal standard solution,
Standard preparation, and
Chromatographic system—Prepare as directed in the
Assay under
Ceftizoxime Sodium.
Assay preparation—
Allow 1 container of Injection to thaw, and mix. Transfer an accurately measured volume of the Injection, equivalent to about 40 mg of ceftizoxime, to a 100-mL volumetric flask, dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Ceftizoxime Sodium. Calculate the quantity, in mg, of ceftizoxime (C
13H
13N
5O
5S
2) in each mL of the Injection taken by the formula:
2000(C / V)(RU / RS),
in which
V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
