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 ceftazidime, the retention time of which corresponds to that exhibited in the chromatogram of the
Standard preparation obtained as directed in the
Assay.
Assay—
pH 7 Buffer
,
Mobile phase,
Standard preparation, Resolution solution, and
Chromatographic system—Proceed as directed in the
Assay under
Ceftazidime.
Assay preparation—
Allow a container of the Injection to thaw, and mix the solution. Transfer an accurately measured volume of the Injection, equivalent to about 50 mg of ceftazidime, to a 50-mL volumetric flask, dilute with pH 7 buffer to volume, and mix. Transfer 5.0 mL of this solution to a second 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Ceftazidime. Calculate the quantity, in mg, of C
22H
22N
6O
7S
2 in each mL of the Injection taken by the formula:
0.5(C / V)(rU / rS),
in which
C is the concentration, in µg per mL, of ceftazidime (C
22H
22N
6O
7S
2) in the
Standard preparation; V is the volume, in mL, of Injection taken; and
rU and
rS are the ceftazidime peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
