» 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.
USP Reference standards 11
USP Endotoxin RS
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.
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 Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2535