U.S. PHARMACOPEIA

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Cefazolin Injection
» Cefazolin Injection is a sterile solution of Cefazolin and Sodium Bicarbonate in a diluent containing one or more suitable tonicity-adjusting agents. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefazolin (C14H14N8O4S3).
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 retention time of the major peak for cefazolin in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 0.15 USP Endotoxin Unit per mg of cefazolin.
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 4.5 and 7.0.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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 Cefazolin.
Assay preparation— Allow 1 container of Injection to thaw, and mix. Transfer an accurately measured volume of the Injection, equivalent to about 50 mg of cefazolin, to a 50-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 Cefazolin. Calculate the quantity, in mg, of cefazolin (C14H14N8O4S3) in each mL of the Injection taken by the formula:
(1000C / V)(RU / RS),
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 407
Phone Number : 1-301-816-8223