Assay
pH6.8buffer
,
Mobile phase,
Resolution solution,
Standard preparation,and
Chromatographic systemPrepare as directed in the
Assayunder
Cefpiramide.
Assay preparation 1
(where it is represented as being in a single-dose container)Constitute a container of Cefpiramide for Injection in a volume of water,accurately measured,corresponding to the volume of diluent 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 the equivalent of about 0.25mg of cefpiramide (C25H24N8O7S2)per mL.
Assay preparation 2
(where the label states the quantity of cefpiramide in a given volume of constituted solution)Constitute a container of Cefpiramide for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 0.25mg of cefpiramide (C25H24N8O7S2)per mL.
Procedure
Proceed as directed for
Procedurein the
Assayunder
Cefpiramide.Calculate the quantity,in mg,of cefpiramide (C
25H
24N
8O
7S
2)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CE/1000)(rU/rS),
in which
Lis the labeled quantity,in mg,of cefpiramide (C
25H
24N
8O
7S
2)in the container,or in the volume of constituted solution taken,
Dis the concentration,in mg of cefpiramide per mL,of
Assay preparation 1or
Assay preparation 2based on the labeled quantity in the container or in the volume of constituted solution taken,respectively,
Cis the concentration,in mg per mL,of
USP Cefpiramide RSin the
Standard preparation,Eis the designated cefpiramide (C
25H
24N
8O
7S
2)content,in µg per mg,of
USP Cefpiramide RS,and
rUand
rSare the cefpiramide peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.