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 90.0percent and not more than 115.0percent of the labeled amount of cefazolin (C14H14N8O4S3).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.15USP Endotoxin Unit per mg of cefazolin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.5and 7.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
pH3.6buffer,pH7.0buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Cefazolin.
Assay preparation— Allow 1container of Injection to thaw,and mix.Transfer an accurately measured volume of the Injection,equivalent to about 50mg of cefazolin,to a 50-mLvolumetric flask,dilute with pH7.0bufferto volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,add 5.0mLof Internal standard solution,dilute with pH7.0bufferto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Cefazolin.Calculate the quantity,in mg,of cefazolin (C14H14N8O4S3)in each mLof the Injection taken by the formula:
(1000C/V)(RU/RS),
in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 375
Phone Number:1-301-816-8335