Cefotetan for Injection
»Cefotetan for Injection contains an amount of Cefotetan Disodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of cefotetan (C17H17N7O8S4).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,the constituted solution meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.17USP Endotoxin Unit per mg of cefotetan.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under 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 Cefotetan Disodium.It meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay— [NOTE—Protect the Standard preparation,the Resolution solution,and the Assay preparations from light,and use within 2hours.]
Solvent— Prepare a mixture of water,methanol,and acetonitrile (90:5:5).
Mobile phase,Solvent,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Cefotetan.
Assay preparation 1 (where the package is represented as being in a single-dose container)—Constitute Cefotetan for Injection as directed in the labeling.Withdraw all of the withdrawable contents,and quantitatively dilute with Solventto obtain a solution containing the equivalent of about 200µg of cefotetan per mL.
Assay preparation 2 (where the label states the quantity of cefotetan in a given volume of constituted solution)—Constitute Cefotetan for Injection as directed in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with Solventto obtain a solution containing the equivalent of about 200µg of cefotetan per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Cefotetan.Calculate the quantity,in mg,of cefotetan (C17H17N7O8S4)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CP)(rU/rS),
in which Lis the labeled quantity,in mg,of cefotetan in the container,or in the volume of constituted solution taken,and Dis the concentration,in µg of cefotetan per mL,of Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container or in the portion of constituted solution taken,respectively,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 391
Phone Number:1-301-816-8335