Aztreonam Injection
»Aztreonam Injection is a sterile solution of Aztreonam and Arginine and a suitable osmolality adjusting substance in Water for Injection.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of aztreonam (C13H17N5O8S2).
Packaging and storage— Preserve in Containers for Sterile Solidsas 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 times of the major peaks in the chromatogram of the Assay preparationcorrespond to those of the Standard preparation,as obtained in the Assay.
Pyrogen á151ñ— It meets the requirements,the test dose being an accurately measured volume of Injection sufficient to provide 50mg of aztreonam per kg.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.5and 7.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Aztreonam for Injection.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with Mobile phaseto obtain a solution containing about 0.2mg of aztreonam per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Aztreonam for Injection.Calculate the quantity,in mg,of aztreonam (C13H17N5O8S2)in the volume of Injection taken by the formula:
(CSPSL/1000D)(rU/rS),
in which CSis the concentration,in mg per mL,of USP Aztreonam RSin the Standard preparation;PSis the assigned purity,in µg per mg,of USP Aztreonam RS;Lis the labeled quantity,in mg,of aztreonam (C13H17N5O8S2)in the volume of Injection taken;Dis the concentration,in mg of aztreonam per mL,based on the labeled quantity in the volume of Injection taken;and rUand rSare the aztreonam peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 211
Phone Number:1-301-816-8335