Cefpiramide for Injection
»Cefpiramide for Injection contains not less than 90.0percent and not more than 120.0percent of the labeled amount of cefpiramide (C25H24N8O7S2).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Identification— The retention time for the cefpiramide peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Pyrogen á151ñ It meets the requirements,the test dose being 1.0mLper kg of a solution prepared by diluting Cefpiramide for Injection with Sterile Water for Injection to a concentration of 50mg of cefpiramide per mL.
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 8.0,in a solution containing the equivalent of 100mg of cefpiramide per mL.
Water,Method Iá921ñ: not more than 3.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
pH6.8buffer ,Mobile phase,Resolution solution,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Cefpiramide.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute a container of Cefpiramide for Injection in a volume of water,accurately measured,corresponding to the volume of diluent 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 the equivalent of about 0.25mg of cefpiramide (C25H24N8O7S2)per mL.
Assay preparation 2 (where the label states the quantity of cefpiramide in a given volume of constituted solution)—Constitute a container of Cefpiramide for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 0.25mg of cefpiramide (C25H24N8O7S2)per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Cefpiramide.Calculate the quantity,in mg,of cefpiramide (C25H24N8O7S2)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CE/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of cefpiramide (C25H24N8O7S2)in the container,or in the volume of constituted solution taken,Dis the concentration,in mg of cefpiramide per mL,of Assay preparation 1or Assay preparation 2based on the labeled quantity in the container or in the volume of constituted solution taken,respectively,Cis the concentration,in mg per mL,of USP Cefpiramide RSin the Standard preparation,Eis the designated cefpiramide (C25H24N8O7S2)content,in µg per mg,of USP Cefpiramide RS,and rUand rSare the cefpiramide 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 396
Phone Number:1-301-816-8335