Identification
Solution:
20µg per mL.
Medium:
0.1Msodium bicarbonate.
B:
The retention time of the major peak for cefazolin in the chromatogram of the
Assay preparationcorresponds to that in the chromatogram of the
Standard preparation,as obtained in the
Assay.
C:
It meets the requirements of the tests for Sodium á191ñ.
Assay
pH3.6buffer,pH7.0buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system
Prepare as directed in the
Assayunder
Cefazolin.
Assay preparation 1
(where it is packaged for dispensing and is represented as being in a single-dose container)Constitute Cefazolin 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 dilute quantitatively with pH7.0bufferto obtain a stock solution containing about 1mg of cefazolin per mL.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,add 5.0mLof Internal standard solution,dilute with pH7.0bufferto volume,and mix.
Assay preparation 2
(where the label states the quantity of cefazolin in a given volume of constituted solution)Constitute Cefazolin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with pH7.0bufferto obtain a stock solution containing about 1mg of cefazolin per mL.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,add 5.0mLof Internal standard solution,dilute with pH7.0bufferto volume,and mix.
Procedure
Proceed as directed in the
Assayunder
Cefazolin.Calculate the quantity,in mg,of cefazolin (C
14H
14N
8O
4S
3)in the container,and in the volume of constituted solution taken by the formula:
(CL/D)(RU/RS),
in which
Lis the labeled quantity,in mg,of cefazolin in the container,or in the volume of constituted solution taken;
Dis the concentration,in mg per mL,of cefazolin in the stock solution used in preparing
Assay preparation 1or
Assay preparation 2,on the basis of the labeled quantity in the container,or in the volume of constituted solution taken,respectively,and the extent of dilution;and the other terms are as defined therein.Where the test for
Uniformity of dosage unitshas been performed using the
Procedure for content uniformity,use the average of these determinations as the
Assayvalue.