Ceforanide
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5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,7-[[[2-(aminomethyl)phenyl]acetyl]amino]-3-[[[1-(carboxymethyl)1H-tetrazol-5-yl]thio]methyl]-8-oxo-,(6R-trans)-.
(6R,7R)-7-[2-(a-Amino-o-tolyl)acetamido]-3-[[[1-(carboxymethyl)-1H-tetrazol-5-yl]thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.
7-[o-(Aminomethyl)phenylacetamido]-3-[[[1-(carboxymethyl)-1H-tetrazol-5-yl]thio]methyl]-3-cephem-4-carboxylic acid [60925-61-3].
»Ceforanide contains not less than 900µg and not more than 1050µg of ceforanide (C20H21N7O6S2)per mg.
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:
Infrared Absorption á197Mñ.
B:
The retention time of the major peak for ceforanide in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ—
Where the label states that Ceforanide is sterile or must be subjected to further processing during the preparation of injectable dosage forms,it contains not more than 0.25USP Endotoxin Unit per mg of ceforanide.
Sterility á71ñ—
Where the label states that Ceforanide is sterile,it meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,except to dissolve 6g of Ceforanide in Fluid Ato each 1000mLof which has been added 10g of sterile L-lysine,and to rinse the membrane with three 100-mLportions of Fluid Dand one 100-mLportion of Fluid A.
pHá791ñ:
between 2.5and 4.5,in a suspension containing 50mg per mL.
Water,Method Iá921ñ:
not more than 5.0%.
Assay—
Mobile phase—
Mix 18mLof tetrabutylammonium hydroxide solution (1in 10)and 8.6mLof 11Npotassium hydroxide,and add the mixture to 700mLof water.Add 200mLof methanol,adjust with phosphoric acid to a pHof 7.0,and add water to obtain 1000mLof solution,making adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).Filter,using a filter having a porosity of 1µm or finer,and degas.
Standard preparation—
Dissolve an accurately weighed quantity of USP Ceforanide RSin Mobile phaseto obtain a solution having a known concentration of about 1mg per mL.Use this solution within 5minutes.
Assay preparation—
Using a suitable quantity of Ceforanide,accurately weighed,proceed as directed under Standard preparation.Use this solution within 5minutes.
Chromatographic system
(see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×30-cm column that contains 5-to 10-µm packing L1.The flow rate is about 1mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed under Procedure:the column efficiency determined from the analyte peak is not less than 1900theoretical plates,the tailing factor for the analyte peak is not more than 1.2,the capacity factor,k¢,is not less than 1.8and not more than 5.0,and the relative standard deviation for replicate injections is not more than 1.5%.
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 C20H21N7O6S2in each mg of the Ceforanide taken by the formula:
(CP/M)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Ceforanide RSin the Standard preparation,Pis the potency,in µg per mg,of the USP Ceforanide RS,Mis the concentration,in mg per mL,of the Assay preparation,based on the amount of Ceforanide taken and the extent of dilution,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 387
Phone Number:1-301-816-8335