Cefoperazone for Injection
» Cefoperazone for Injection contains an amount of Cefoperazone Sodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefoperazone (C25H27N9O8S2).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.20 USP Endotoxin Unit per mg of cefoperazone.
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 4.5 and 6.5, in a solution (1 in 4).
Water, Method I 921: 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 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements for the Identification tests under Cefoperazone Sodium and meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under 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 phase to obtain a solution containing about 0.16 mg 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 phase to obtain a solution containing about 0.16 mg of cefoperazone per mL.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg of cefoperazone (C25 H27N9O8S2) per mL, of the Standard preparation; M is the concentration, in mg per mL, of the Assay preparation based on the weight of Cefoperazone for Injection taken and the extent of dilution; and rU and rS are the peak responses obtained from the Assay preparation and 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 L is the labeled quantity, in mg, of cefoperazone (C25 H27N9O8S2), in the container, or in the volume of constituted solution taken; and D is the concentration, in mg of cefoperazone (C25H27N9O8S2) 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, and the extent of dilution; and the other terms are as defined therein.
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USP35NF30 Page 2555