Cefonicid for Injection
» Cefonicid for Injection contains an amount of Cefonicid Sodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefonicid (C18H18N6O8S3).
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 0.35 USP Endotoxin Unit per mg of cefonicid.
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 Specific rotation, pH, and Water under Cefonicid Sodium. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Mobile phase Prepare a mixture of water, methanol, and 0.2 M monobasic ammonium phosphate (33:5:3). Pass through a filter having a 0.5-µm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve an accurately weighed quantity of USP Cefonicid Sodium RS in Mobile phase to obtain a solution having a known concentration of about 200 µg of cefonicid (C18H18N6O8S3) per mL.
Assay preparation 1 (where it is represented as being in a single-dose container)Constitute Cefonicid 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 200 µg of cefonicid per mL.
Assay preparation 2 (where the label states the quantity of cefonicid in a given volume of constituted solution)Constitute Cefonicid 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 200 µg of cefonicid per mL.
Resolution solution Dissolve a quantity of USP Cefonicid Sodium RS in Mobile phase to obtain a solution containing about 0.2 mg per mL. Heat on a steam bath for 30 minutes, and cool. This Resolution solution contains a mixture of cefonicid and desacetyl cefonicid.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 254-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation and the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between the cefonicid peak and the desacetyl cefonicid peak is not less than 1.1; the column efficiency determined from the analyte peak is not less than 1500 theoretical plates; the tailing factor for the analyte peak is not more than 2.0; and the relative standard deviation for replicate injections of the Standard preparation is not more than 2%.
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 mg, of cefonicid (C18H18N6O8S3) 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 cefonicid in the container, or in the volume of constituted solution taken; D is the concentration, in µg per mL, of cefonicid in 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; C is the concentration, in µg per mL, of cefonicid in the Standard preparation; and rU and rS are the peak responses obtained from the relevant Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2553Pharmacopeial Forum: Volume No. 32(1) Page 67