Cefonicid Sodium
;)
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,7-[(hydroxyphenylacetyl)amino]-8-oxo-3-[[[1-(sulfomethyl)-1H-tetrazol-5-yl]thio]methyl]disodium salt,[6R-[6a,7b(R*)]]-.
(6R,7R)-[7-[(R)-Mandelamido]-8-oxo-3-[[[1-(sulfomethyl)-1-H-tetrazol-5-yl]thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,disodium salt [61270-78-8].
»Cefonicid Sodium contains the equivalent of not less than 832µg and not more than 970µg of cefonicid (C18H18N6O8S3)per mg,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms,the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification—
A:
The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for cefonicid,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation,as obtained in the Assay.
B:
It responds to the tests for Sodium á191ñ.
Specific rotation á781Sñ:
between -37
and -47.
and -47.
Test solution:
10mg per mL,in methanol.
pHá791ñ:
between 3.5and 6.5,in a solution (1in 20).
Water,Method Iá921ñ:
not more than 5.0%.
Other requirements—
Where the label states that Cefonicid Sodium is sterile,it meets the requirements for Sterilityand Bacterial endotoxinsunder Cefonicid for Injection.Where the label states that Cefonicid Sodium must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements for Bacterial endotoxinsunder Cefonicid for Injection.
Assay—
Mobile phase—
Prepare a mixture of water,methanol,and 0.2Mmonobasic ammonium phosphate (33:5:2).Pass through a filter having a 0.5-µm or finer porosity,and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation—
Dissolve an accurately weighed quantity of USP Cefonicid Sodium RSin Mobile phaseto obtain a solution having a known concentration of about 200µg of cefonicid (C18H18N6O8S3)per mL.
Assay preparation—
Transfer about 40mg of Cefonicid Sodium,accurately weighed,to a 200-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.
Resolution solution—
Dissolve a quantity of USP Cefonicid Sodium RSin Mobile phaseto obtain a solution containing about 0.2mg per mL.Heat on a steam bath for 30minutes,and cool.This Resolution solutioncontains a mixture of cefonicid and desacetyl cefonicid.
Chromatographic system
(see Chromatography á621ñ)—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 2mLper minute.Chromatograph the Standard preparationand the Resolution solution,and record the peak responses as directed for Procedure:the resolution R,between the cefonicid and the desacetyl cefonicid peaks is not less that 1.1;the column efficiency determined from the analyte peak is not less than 1500theoretical 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 preparationis not more than 2%.
Procedure—
Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in µg,of cefonicid (C18H18N6O8S3)per mg of the Cefonicid Sodium taken by the formula:
200(C/M)(rU/rS),
in which Cis the concentration,in µg per mLof cefonicid (C18H18N6O8S3)in the Standard preparation;Mis the quantity,in mg,of Cefonicid Sodium taken to prepare the Assay preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 384
Phone Number:1-301-816-8335