Cefoxitin for Injection
»Cefoxitin for Injection contains Cefoxitin Sodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of cefoxitin (C16H17N3O7S2).
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.
Bacterial endotoxins á85ñ It contains not more than 0.13USP Endotoxin Unit per mg of cefoxitin.
Sterility á71ñ It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It responds to the Identificationtests and meets the requirements for pHand Waterunder Cefoxitin Sodium.It meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Mobile phase ,Phosphate buffer,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Cefoxitin Sodium.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Cefoxitin 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 water to obtain a solution having a concentration of about 0.3mg of cefoxitin per mL.Use this solution within 5hours.
Assay preparation 2 (where the label states the quantity of cefoxitin in a given volume of constituted solution)—Constitute Cefoxitin 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 water to obtain a solution containing about 0.3mg of cefoxitin per mL.Use this solution within 5hours.
Procedure— Proceed as directed in the Assayunder Cefoxitin Sodium.Calculate the quantity,in mg,of cefoxitin (C16H17N3O7S2)in the portion of constituted solution taken by the formula:
0.001(CP)(L/D)(rU/rS),
in which Lis the labeled quantity,in mg,in the portion of constituted solution taken,Dis the concentration,in mg per mL,of Assay preparation 1or Assay preparation 2,based on the volume of constituted solution taken and the extent of dilution,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 395
Phone Number:1-301-816-8335