Iohexol Injection
»Iohexol Injection is a sterile solution of Iohexol in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of Iohexol (C19H26I3N3O9)as organically bound iodine.It may contain small amounts of suitable buffers and of Edetate Calcium Disodium as a stabilizer.Iohexol 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 of Type Iglass,protected from light.
Labeling— Label containers of Injection to direct the user to discard any unused portion.The labeling states also that it is not to be used if it is discolored or contains a precipitate.Label it also to state its routes of administration.
Identification—
A: Evaporate 1mLof Injection to dryness,and heat the residue so obtained in a crucible:violet vapors are evolved.
B: Dilute a volume of Injection with methanol to obtain a test solution having a concentration of 10mg per mL.The test solution responds to theThin-layer Chromatographic Identification Test á201ñ,the Standard solution being prepared at a concentration of 10mg of USP Iohexol RSper mLin methanol,the solvent mixture being a mixture of n-butyl alcohol,water,and glacial acetic acid (50:25:11),and short-wavelength UVlight being used to locate the spots.
Bacterial endotoxins á85ñ— It contains not more than 0.2USP Endotoxin Unit per 50mg of iodine.
pHá791ñ: between 6.8and 7.7.
Particulate matter á788ñ— The Injection labeled for intrathecal use meets the requirements for small-volume injections.
Free iodide— Transfer 5.0mLof Injection to a suitable container,add about 20mLof water,and titrate with 0.001Nsilver nitrate VSdetermining the endpoint potentiometrically using a silver electrode in combination with an appropriate reference electrode.Each mLof 0.001Nsilver nitrate is equivalent to 0.1269mg of I(not more than 0.02%,based on the content of iohexol).
Other requirements— It meets the requirements underInjections á1ñ,and meets the requirements forHeavy metals and Related compoundsunderIohexol.
Assay for iodine— Transfer an accurately measured volume of Injection,equivalent to about 300mg of iodine,to a glass-stoppered,250-mLconical flask.Proceed as directed in theAssay underIohexol,beginning with “Add 25mLof 1.25Nsodium hydroxide.”
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1045
Pharmacopeial Forum:Volume No.28(2)Page 308
Phone Number:1-301-816-8305