Iopamidol Injection
»Iopamidol Injection is a sterile solution of Iopamidol in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of iopamidol (C17H22I3N3O8).It may contain small amounts of suitable buffers and of Edetate Calcium Disodium as a stabilizer.Iopamidol Injection intended for intravascular or intrathecal use contains no antimicrobial agents.
Packaging and storage— Preserve Injection intended for intravascular or intrathecal use in single-dose containers,preferably of Type Iglass,and protected from light.
Labeling— Label containers of Injection to direct the user to discard any unused portion remaining in the container and to check for the presence of particulate matter before using.Label it also to state its routes of administration.
Identification—
A: Evaporate a volume of Injection,equivalent to about 500mg of iopamidol,to dryness,and heat the residue so obtained in a suitable crucible:violet vapors are evolved.
B: It responds to the Thin-Layer Chromatographic Identification Test á201ñ,the test solution and the Standard solution being prepared at a concentration of 0.5mg per mLin a mixture of methanol and water (9:1),the solvent mixture being chloroform,methanol,ammonium hydroxide,and water (60:30:9:1),and short-wavelength UVlight being used to locate the spots.
Bacterial endotoxins á85ñ— It contains not more than 0.6USP Endotoxin Unit per mg of iodine.
pHá791ñ: between 6.5and 7.5.
Particulate matter á788ñ— The Injection labeled for intrathecal use meets the requirements for small-volume injections.
Free aromatic amine— Transfer an accurately measured volume of Injection,equivalent to about 500mg of iopamidol,to a 25-mLvolumetric flask,dilute with water to 20mL,and mix.To a second 25-mLvolumetric flask transfer 16mLof water and 4.0mLof Standard solution prepared by dissolving a suitable quantity of USP Iopamidol Related Compound A RSin water and diluting with water to obtain a solution having a concentration of 62.5µg per mL.Proceed as directed in the test for Free aromatic amineunder Iopamidol,beginning with “to the third 25-mLvolumetric flask add 20mLof water.”The absorbance of the solution from the iopamidol is not greater than that of the Standard solution (0.05%).
Free iodine— Transfer a volume of Injection,equivalent to 2.0g of iopamidol,to a glass-stoppered test tube.Add 2mLof 2Nsulfuric acid and 1.0mLof toluene,shake,and allow the layers to separate:the toluene layer shows no red color.
Limit of free iodide— Transfer 10.0mLof Injection to a beaker,add 40mLof water,and mix.Proceed as directed in the Limit of free iodidetest under Iopamidolbeginning with “add 2.0mLof 0.001Mpotassium iodide.”Not more than 3.1mLof 0.001Nsilver nitrate is required (0.04mg of iodide per mL).
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Solution A,Solution B,Mobile phase,System suitability solution,and Chromatographic system— Proceed as directed in the test for Related compoundsunder Iopamidol.
Standard preparation— Dissolve about 20mg of USP Iopamidol RS,accurately weighed,in about 10mLof water,and dilute quantitatively and stepwise with water to obtain a solution having a known concentration of about 80µg of USP Iopamidol RSper mL.
Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 1000mg of iopamidol,quantitatively and stepwise with water to obtain a solution having a concentration of about 80µg of iopamidol per mL.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of iopamidol (C17H22I3N3O8)in the portion of Injection taken by the formula:
12.5C(rU/rS),
in which Cis the concentration,in µg per mL,of USP Iopamidol RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1047
Phone Number:1-301-816-8305