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.
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 (C
19H
19N
3O
5S)in each mLof the Injection taken by the formula:
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.