Cefpiramide for Injection
» Cefpiramide for Injection contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefpiramide (C25H24N8O7S2).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
Identification The retention time for the cefpiramide peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation; as obtained in the Assay.
Pyrogen 151 It meets the requirements, the test dose being 1.0 mL per kg of a solution prepared by diluting Cefpiramide for Injection with Sterile Water for Injection to a concentration of 50 mg of cefpiramide per mL.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 6.0 and 8.0, in a solution containing the equivalent of 100 mg of cefpiramide per mL.
Water, Method I 921: not more than 3.0%.
Particulate matter 788: meets the requirements for small-volume injections.
pH 6.8 Buffer , Mobile phase, Resolution solution, Standard preparation, and Chromatographic systemPrepare as directed in the Assay under 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 phase to obtain a solution containing the equivalent of about 0.25 mg 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 0.25 mg of cefpiramide (C25H24N8O7S2) per mL.
Procedure Proceed as directed for Procedure in the Assay under 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 Calculate the quantity, in mg, of cefpiramide (C25H24N8O7S2) withdrawn from the container, or in the portion of constituted solution taken by the formula: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 L is the labeled quantity, in mg, of cefpiramide (C25H24N8O7S2) in the container, or in the volume of constituted solution taken; D is the concentration, in mg of cefpiramide per mL, of Assay preparation 1 or Assay preparation 2 based on the labeled quantity in the container or in the volume of constituted solution taken, respectively; C is the concentration, in mg per mL, of USP Cefpiramide RS in the Standard preparation; E is the designated cefpiramide (C25H24N8O7S2) content, in µg per mg, of USP Cefpiramide RS; and rU and rS are the cefpiramide peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2566Pharmacopeial Forum: Volume No. 37(3)