» Ceftazidime Injection is a sterile isoosmotic solution of Ceftazidime in Water for Injection. It contains one or more suitable buffers and a tonicity-adjusting agent. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C22H22N6O7S2.
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.
USP Reference standards 11
USP Ceftazidime Delta-3-Isomer RS
USP Endotoxin RS
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.
Bacterial endotoxins 85 It contains not more than 0.1 USP Endotoxin Unit per mg of ceftazidime.
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.
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 C22H22N6O7S2 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 (C22H22N6O7S2) 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.
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USP35NF30 Page 2572Pharmacopeial Forum: Volume No. 34(4) Page 907