Cefmetazole for Injection
»Cefmetazole for Injection contains an amount of Cefmetazole Sodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of cefmetazole (C15H17N7O5S3).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Bacterial endotoxins á85ñ It contains not more than 0.2USP Endotoxin Unit per mg of cefmetazole.
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 meets the requirements in the tests for Identification,pH,and Waterunder Cefmetazole Sodium.It meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,andChromatographic system— Proceed as directed in the Assayunder Cefmetazole.
Assay preparation 1(where it is represented as being in a single-dose container) Constitute Cefmetazole 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 0.2mg of cefmetazole per mL.[NOTE—Use this solution within 10minutes.]
Assay preparation 2(where the label states the quantity of cefmetazole in a given volume of constituted solution) Constitute Cefmetazole 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 0.2mg of cefmetazole per mL.[NOTE—Use this solution within 10minutes.]
Procedure— Proceed as directed in the Assayunder Cefmetazole.Calculate the quantity,in mg,of cefmetazole (C15H17N7O5S3)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(C/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of cefmetazole in the container,or in the volume of constituted solution taken;Dis the concentration,in mg per mL,of cefmetazole (C15H17N7O5S3)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;Cis the concentration,in µg per mL,of cefmetazole (C15H17N7O5S3)in the Standard preparation;and rUand rSare the cefmetazole peak responses obtained from the relevant 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 383
Pharmacopeial Forum:Volume No.27(2)Page 2127
Phone Number:1-301-816-8335