Nafcillin for Injection
»Nafcillin for Injection 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).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
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,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: between 3.5%and 5.3%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
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 1 (where it is represented as being in a single-dose container)—Constitute Nafcillin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with Diluentto obtain a solution having a concentration of about 0.4mg of nafcillin (C21H22N2O5S)per mL.
Assay preparation 2 (where the label states the quantity of nafcillin in a given volume of constituted solution)—Constitute Nafcillin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with Diluentto obtain a solution having a concentration of about 0.4mg of nafcillin (C21H22N2O5S)per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Nafcillin Sodium.Calculate the quantity,in mg,of nafcillin (C21H22N2O5S)in the portion of constituted Nafcillin for Injection taken by the formula:
(C/1000)(L/D)(rU/rS),
in which Lis the labeled quantity,in mg,of nafcillin in the portion of Nafcillin for Injection taken;Dis the concentration,in mg per mL,of nafcillin in Assay preparation 1or Assay preparation 2,as appropriate,based on the volume of constituted Nafcillin for Injection taken and the extent of dilution;and the other terms are as defined therein.
Perform the above procedure on 10containers where it is represented as being in a single-dose container and,if necessary,on 10containers where the label states the quantity of nafcillin in a given volume of constituted solution.Use the individual results to determine the Uniformity of dosage unitsand the average thereof as the Assayvalue.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1324
Phone Number:1-301-816-8335