Ioxaglate Meglumine and Ioxaglate Sodium Injection
»Ioxaglate Meglumine and Ioxaglate Sodium Injection is a sterile solution of Ioxaglic Acid in Water for Injection,prepared with the aid of Meglumine and Sodium Hydroxide.It contains not less than 95.0percent and not more than 105.0percent of the labeled amounts of ioxaglate meglumine (C24H21I6N5O8·C7H17NO5)and iodine (I).It may contain small amounts of Edetate Calcium Disodium as a stabilizer.Ioxaglate Meglumine and Ioxaglate Sodium Injection intended for intravascular use contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.
Labeling— Label containers of Injection intended for intravascular injection to direct the user to discard any unused portion remaining in the container.Label containers of Injection intended for other than intravascular injection to indicate that the contents are not intended for intravascular injection.
Identification—
A: It responds to Identificationtest Aunder Ioxaglic Acid,a solution of 1.7mLof Injection in 100mLof water being used as the test solution.
B: Evaporate a volume of Injection,equivalent to about 500mg of ioxaglate meglumine and ioxaglate sodium,to dryness,and heat the residue so obtained in a crucible:violet vapors are evolved.
pHá791ñ: between 6.0and 7.6.
Heavy metals—
Test solution— Transfer a volume of Injection,equivalent to a total of 1.0g of ioxaglate meglumine and ioxaglate sodium,to a 50-mLcolor-comparison tube,and dilute with water to 5mL.
Standard solution— Transfer 2.0mLof Standard Lead Solution(20µg of Pb)(see Heavy Metals á231ñ)to a 50-mLcolor-comparison tube,and dilute with water to 5mL.
Procedure— Add 1.0mLof ferrous sulfate solution (1in 1000)to the Test solutionand the Standard solution,adjust the solutions with 1Nacetic acid to a pHbetween 3and 4,add 10mLof hydrogen sulfide TS,mix,allow to stand for 5minutes,and view downward over a white surface:the color of the solution from the Test solutionis not darker than that of the solution from the Standard solution(0.002%).
Free iodine and iodide—
Test solution— Transfer a volume of Injection,equivalent to 2g of the total of ioxaglate meglumine and iothalamate sodium,to a 50-mLcentrifuge tube,add 25mLof water and 15mLof 2Nsulfuric acid,and mix thoroughly.Centrifuge for 15minutes,and decant the supernatant layer into a glass-stoppered 50-mLgraduated cylinder.Repeat the sulfuric acid washing and centrifugation once more,adding the supernatant layer into the 50-mLgraduated cylinder.
Procedure— Proceed as directed for Procedurein the test for Free iodine and iodideunder Ioxaglic Acid(0.02%of iodide).
Other requirements— It meets the requirements under Injections á1ñ.
Assay for ioxaglate meglumine— Determine the angular rotation (see Optical Rotation á781ñ)of the Injection,using a 10-cm cell and a suitable polarimeter.Calculate the percentage of ioxaglate meglumine in the Injection taken by the formula:
100a/3.32,
in which ais the observed angular rotation,in degrees,corrected for a water blank,and 3.32is the specific rotation,in degrees,of ioxaglate meglumine.
Assay for iodine— Transfer an accurately measured volume of Injection,equivalent to about 5g (total)of ioxaglate meglumine and ioxaglate sodium,to a 250-mLvolumetric flask,dilute with water to volume,and mix.Pipet 25mLof this solution into a 125-mLconical flask,add 12mLof 5Nsodium hydroxide and 1g of powdered zinc,connect the flask to a reflux condenser,and reflux for 30minutes.Proceed as directed in the Assay for iodineunder Ioxaglic Acid.Each mLof 0.05Nsilver nitrate is equivalent to 6.345mg of iodine (I).
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1055
Phone Number:1-301-816-8305
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