» Oxacillin Injection is a sterile isoosmotic solution of Oxacillin Sodium in Water for Injection. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent 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 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.
Identification The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for oxacillin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Pyrogen It meets the requirements of the Pyrogen Test 151, the test dose being a volume of undiluted Injection providing the equivalent of 20 mg of oxacillin per kg.
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 6.0 and 8.5.
Particulate matter 788: meets the requirements for small-volume injections.
Mobile phase , Standard preparation, and Chromatographic systemProceed as directed in the Assay under Oxacillin Sodium.
Assay preparation Allow one container of Injection to thaw, and mix. Transfer an accurately measured volume of Injection, equivalent to about 50 mg of oxacillin, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, dilute with water to volume, and mix. [noteUse this Assay preparation on the day prepared.]
Procedure Proceed as directed for Procedure in the Assay under Oxacillin Sodium. Calculate the quantity, in mg, of oxacillin (C19H19N3O5S) in each mL of the Injection taken by the formula:
0.5(CE / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Oxacillin Sodium RS in the Standard preparation, E is the oxacillin equivalent, in µg per mg, of USP Oxacillin Sodium RS, V is the volume, in mL, of Injection taken to prepare the Assay preparation, and rU and rS are the oxacillin peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3148