Assay
Mobile phase,Standard preparation,Resolution solution,andChromatographic system
Proceed as directed in the Assayunder Cefmetazole.
Assay preparation 1(where it is represented as being in a single-dose container)
Constitute Cefmetazole 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 phaseto obtain a solution containing about 0.2mg of cefmetazole per mL.[NOTEUse this solution within 10minutes.]
Assay preparation 2(where the label states the quantity of cefmetazole in a given volume of constituted solution)
Constitute Cefmetazole 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 phaseto obtain a solution containing about 0.2mg of cefmetazole per mL.[NOTEUse this solution within 10minutes.]
Procedure
Proceed as directed in the
Assayunder
Cefmetazole.Calculate the quantity,in mg,of cefmetazole (C
15H
17N
7O
5S
3)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(C/1000)(rU/rS),
in which
Lis the labeled quantity,in mg,of cefmetazole in the container,or in the volume of constituted solution taken;
Dis the concentration,in mg per mL,of cefmetazole (C
15H
17N
7O
5S
3)per mL,of
Assay preparation 1or
Assay preparation 2,based on the labeled quantity in the container or in the portion of constituted solution taken,respectively;
Cis the concentration,in µg per mL,of cefmetazole (C
15H
17N
7O
5S
3)in the
Standard preparation;and
rUand
rSare the cefmetazole peak responses obtained from the relevant
Assay preparationand the
Standard preparation,respectively.