Chromatographic purity—
Using the chromatogram of the
Assay preparationobtained in the
Assay,calculate the percentage of each impurity by the formula:
100ri/(ris+rc),
in which
riis the peak area response of a given impurity,
risis the sum of all the impurity peak area responses,and
rcis the peak area response for the main cefotaxime peak.
[NOTE—Disregard any impurity peak that is less than 0.1%.
]Not more than 6.0%of any individual impurity is found,and the sum of all impurities found is not more than 10.0%.
Assay—
0.05M Phosphate buffer,Solution A,Solution B,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—
Prepare as directed in the
Assayunder
Cefotaxime Sodium.
Assay preparation 1
(for use where the Weight Variationtest is to be performed)—Transfer about 40mg of Cefotaxime for Injection,accurately weighed,to a 50-mLvolumetric flask,add about 40mLof Solution A,swirl to dissolve,dilute with Solution Ato volume,and mix.[NOTE—Use this solution promptly.It may be used within 24hours if stored in the refrigerator.]
Assay preparation 2
(for use in assaying vials and infusion bottles packaged for dispensing)—Constitute 1container of Cefotaxime for Injection with the smallest volume of diluent specified in the labeling.Invert the container,and withdraw all of the withdrawable contents of the container with a hypodermic needle and syringe.Transfer the contents of the syringe to a 100-mLvolumetric flask,dilute with Solution Ato volume,and mix.[NOTE—Do not rinse the syringe or container.]Dilute an accurately measured volume of this solution quantitatively with Solution Ato obtain a solution having a concentration of about 0.8mg of cefotaxime (C16H17N5O7S2)per mL.[NOTE—Use this solution promptly.It may be used within 24hours if stored in the refrigerator.]
Assay preparation 3
(for use in assaying piggyback infusion bottles)—Constitute 1container of Cefotaxime for Injection with the smallest volume of diluent recommended in the labeling,using the directions specified in the labeling.Proceed as directed for Assay preparation beginning with “Invert the container....”
Assay preparation 4
(for use in assaying pharmacy bulk packages where the label states the quantity of cefotaxime in a given volume of constituted solution)—Constitute 1container of Cefotaxime for Injection with the volume of diluent,accurately measured,specified in the labeling.With a hypodermic needle and syringe,withdraw an accurately measured portion of the resultant solution,equivalent to about 1000mg of cefotaxime,to a 100-mLvolumetric flask,dilute with Solution Ato volume,and mix.[NOTE—Do not rinse the syringe or container.]Dilute an accurately measured volume of this solution quantitatively with Solution Ato obtain a solution having a concentration of about 0.8mg of cefotaxime (C16H17N5O7S2)per mL.[NOTE—Use this solution promptly.It may be used within 24hours if stored in the refrigerator.]
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Cefotaxime Sodium.Calculate the quantity,in µg,of cefotaxime (C
16H
17N
5O
7S
2)in each mg of the Cefotaxime for Injection taken by the formula:
50(CP/W)(rU/rS),
in which
Wis the weight,in mg,of the Cefotaxime for Injection taken,and the other terms are as defined therein.Calculate the quantity,in mg,of cefotaxime in the container,and in the portion of constituted solution taken by the formula:
(CP)(L/1000D)(rU/rS),
in which
Lis the labeled quantity,in mg,of cefotaxime in the container,or in the volume of constituted solution taken,and
Dis the concentration,in mg per mL,of cefotaxime in
Assay preparation 2or in
Assay preparation 3,or in
Assay preparation 4,on the basis of the labeled quantity in the container,or in the portion 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.