Oxacillin Injection
»Oxacillin Injection is a sterile isoosmotic solution of Oxacillin Sodium 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 oxacillin (C19H19N3O5S).It contains dextrose as a tonicity-adjusting agent and one or more suitable buffer substances.It contains no preservatives.
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 oxacillin,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Pyrogen— It meets the requirements of the Pyrogen Test á151ñ,the test dose being a volume of undiluted Injection providing the equivalent of 20mg of oxacillin per kg.
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 8.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Oxacillin Sodium.
Assay preparation— Allow one container of Injection to thaw,and mix.Transfer an accurately measured volume of Injection,equivalent to about 50mg of oxacillin,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 50-mLvolumetric flask,dilute with water to volume,and mix.[NOTE—Use this Assay preparation on the day prepared.]
Procedure— Proceed as directed for Procedurein the Assayunder Oxacillin Sodium.Calculate the quantity,in mg,of oxacillin (C19H19N3O5S)in each mLof the Injection taken by the formula:
0.5(CE/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Oxacillin Sodium RSin the Standard preparation,Eis the oxacillin equivalent,in µg per mg,of USP Oxacillin Sodium RS,Vis the volume,in mL,of Injection taken to prepare the Assay preparation,and rUand rSare the oxacillin 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 1425
Phone Number:1-301-816-8335