Nafcillin Injection
»Nafcillin Injection is a sterile isoosmotic solution of Nafcillin Sodium and one or more buffer substances in Water for Injection.It contains dextrose as a tonicity-adjusting agent.It contains an amount of nafcillin sodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of nafcillin (C21H22N2O5S).It contains no antimicrobial 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 retention time of the major peak for nafcillin in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.13USP Endotoxin Unit per mg of nafcillin.
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—
Acetic acid solution,0.05M Sodium acetate ,Diluent,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—Proceed as directed in the Assayunder Nafcillin Sodium.
Assay preparation— Allow one container of Injection to thaw,and mix.Transfer an accurately measured volume of Injection,equivalent to about 40mg of nafcillin,to a 100-mLvolumetric flask,dilute with Diluentto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Nafcillin Sodium.Calculate the quantity,in mg,of nafcillin (C21H22N2O5S)in each mLof the Injection taken by the formula:
0.1(C/V)(rU/rS),
in which Cis the concentration,in µg per mL,of nafcillin in the Standard preparation;Vis the volume,in mL,of Injection taken to prepare the Assay preparation;and rUand rSare the nafcillin 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 1323
Phone Number:1-301-816-8335