Ceftriaxone Injection
»Ceftriaxone Injection is a sterile solution of Ceftriaxone Sodium in a diluent containing one or more tonicity-adjusting agents in Water for Injection.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of ceftriaxone (C18H18N8O7S3).
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 chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for ceftriaxone,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.20USP Endotoxin Unit per mg of ceftriaxone.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 6.0and 8.0.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
pH7.0buffer ,pH5.0buffer,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—Prepare as directed in the Assayunder Ceftriaxone Sodium.
Assay preparation— Allow 1container of Injection to thaw,and mix.Transfer an accurately measured volume of the Injection,equivalent to about 40mg of ceftriaxone,to a 200-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Use this solution promptly after preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Ceftriaxone Sodium.Calculate the quantity,in mg,of ceftriaxone (C18H18N8O7S3)in each mLof the Injection taken by the formula:
200(C/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 406
Phone Number:1-301-816-8335