Cefoperazone for Injection
»Cefoperazone for Injection contains an amount of Cefoperazone Sodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of cefoperazone (C25H27N9O8S2).
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 0.20USP Endotoxin Unit per mg of cefoperazone.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 4.5and 6.5,in a solution (1in 4).
Water,Method Iá921ñ: not more than 5.0%,except that where it is in the freeze-dried form,the limit is not more than 2.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for the Identificationtests under Cefoperazone Sodiumand meets the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Cefoperazone Sodium.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Cefoperazone 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 quantitatively dilute with Mobile phaseto obtain a solution containing about 0.16mg of cefoperazone per mL.
Assay preparation 2 (where the label states the quantity of cefoperazone in a given volume of constituted solution)—Constitute Cefoperazone for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with Mobile phaseto obtain a solution containing about 0.16mg of cefoperazone per mL.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in µg of cefoperazone per mg,of the Cefoperazone for Injection taken by the formula:
1000(C/M)(rU/rS),
in which Cis the concentration,in mg of cefoperazone (C25H27N9O8S2)per mL,of the Standard preparation;Mis the concentration,in mg per mL,of the Assay preparationbased on the weight of Cefoperazone for Injection taken and the extent of dilution;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.Calculate the quantity,in mg,of cefoperazone (C25H27N9O8S2),withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(C)(rU/rS),
in which Lis the labeled quantity,in mg,of cefoperazone (C25H27N9O8S2),in the container,or in the volume of constituted solution taken;and Dis the concentration,in mg of cefoperazone (C25H27N9O8S2)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 386
Phone Number:1-301-816-8335