Cefmetazole Sodium
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5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,7-[[[(cyanomethyl)thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-,monosodium salt,(6R-cis)-.
Sodium (6R,7S)-7-[2-[(cyanomethyl)thio]acetamido]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate [56796-39-5].
»Cefmetazole Sodium contains the equivalent of not less than 860µg and not more than 1003µg of cefmetazole (C15H17N7O5S3)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:
Infrared Absorption á197Mñ.
B:
The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
pHá791ñ:
between 4.2and 6.2,in a solution (1in 10).
Water,Method Iá921ñ:
not more than 0.5%.
Other requirements —
Where the label states that Cefmetazole Sodium is sterile,it meets the requirements in the tests for Sterility á71ñand for Bacterial endotoxinsunder Cefmetazole for Injection.Where the label states that Cefmetazole Sodium must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements in the test for Bacterial endotoxinsunder Cefmetazole for Injection.
Assay —
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—
Proceed as directed in the Assayunder Cefmetazole.
Assay preparation—
Transfer about 21mg of Cefmetazole Sodium,accurately weighed,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.[NOTE—Use this solution within 10minutes.]
Procedure—
Proceed as directed in the Assayunder Cefmetazole.Calculate the quantity,in µg,of cefmetazole (C15H17N7O5S3)per mg of Cefmetazole Sodium taken by the formula:
100(C/M)(rU/rS),
in which Cis the concentration,in µg per mL,of cefmetazole (C15H17N7O5S3)in the Standard preparation;Mis the quantity,in mg,of Cefmetazole Sodium taken to prepare the Assay preparation;and rUand rSare the cefmetazole 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 383
Pharmacopeial Forum:Volume No.27(2)Page 2127
Phone Number:1-301-816-8335