Cefmetazole for Injection
» Cefmetazole for Injection contains an amount of Cefmetazole Sodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefmetazole (C15H17N7O5S3).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Bacterial endotoxins 85 It contains not more than 0.2 USP Endotoxin Unit per mg of cefmetazole.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements in the tests for Identification, pH, and Water under Cefmetazole Sodium. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under 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 phase to obtain a solution containing about 0.2 mg of cefmetazole per mL. [noteUse this solution within 10 minutes. ]
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 phase to obtain a solution containing about 0.2 mg of cefmetazole per mL. [noteUse this solution within 10 minutes. ]
Procedure Proceed as directed in the Assay under 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 Calculate the quantity, in mg, of cefmetazole (C15H17N7O5S3) withdrawn from the container, or in the portion of constituted solution taken by the formula: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 L is the labeled quantity, in mg, of cefmetazole in the container, or in the volume of constituted solution taken; D is the concentration, in mg per mL, of cefmetazole (C15H17N7O5S3) per mL, of Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively; C is the concentration, in µg per mL, of cefmetazole (C15H17N7O5S3) in the Standard preparation; and rU and rS are the cefmetazole peak responses obtained from the relevant Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2552Pharmacopeial Forum: Volume No. 27(2) Page 2127