Cefoxitin for Injection
» Cefoxitin for Injection contains Cefoxitin Sodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefoxitin (C16H17N3O7S2).
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 0.13 USP Endotoxin Unit per mg of cefoxitin.
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 responds to the Identification tests and meets the requirements for pH and Water under Cefoxitin Sodium. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay
Mobile phase
, Phosphate buffer, Standard preparation, and Chromatographic systemPrepare as directed in the Assay under Cefoxitin Sodium.
Assay preparation 1
(where it is represented as being in a single-dose container)Constitute Cefoxitin 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 dilute quantitatively with water to obtain a solution having a concentration of about 0.3 mg of cefoxitin per mL. Use this solution within 5 hours.
Assay preparation 2
(where the label states the quantity of cefoxitin in a given volume of constituted solution)Constitute Cefoxitin for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing about 0.3 mg of cefoxitin per mL. Use this solution within 5 hours.
Procedure
Proceed as directed in the Assay under Cefoxitin Sodium. Calculate the quantity, in mg, of cefoxitin (C16H17N3O7S2) in the portion of constituted solution taken by the formula:
0.001(CP)(L / D)(rU / rS)
in which L is the labeled quantity, in mg, in the portion of constituted solution taken; D is the concentration, in mg per mL, of Assay preparation 1 or Assay preparation 2, based on the volume of constituted solution taken and the extent of dilution; and the other terms are as defined therein.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1851
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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