Iodixanol Injection
»Iodixanol Injection is a sterile solution of Iodixanol in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of iodixanol (C35H44I6N6O15),as organically bound iodine.It may contain stabilizers and buffers.It contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers of Type Iglass,protected from light,or in plastic containers.
Identification—
A: Evaporate 1mLof Injection to dryness,and heat the residue in a crucible:violet vapors are evolved.
B: The retention times of the two major peaks in the chromatogram of the Test solutioncorrespond to those in the chromatogram of Standard solution 2,as obtained in Chromatographic purity,Test 2.
Bacterial endotoxins á85ñ: not more than 0.2USP Endotoxin Unit per 50mg of iodine.
pHá791ñ: between 6.8and 7.7.
Osmolarity á785ñ: between 270and 310mOsmol per kg.
Limit of free iodide— Transfer 5.0mLof Injection to a suitable container,add 2.0mLof acetic acid solution and about 30mLof water,and titrate with 0.001Nsilver nitrate VS,determining the endpoint potentiometrically.Each mLof 0.001Nsilver nitrate is equivalent to 0.1269mg of iodine.Not more than 15.0mLof 0.001Nsilver nitrate is required:not more than 20mg of iodide per g is found.
Related compounds—
TEST1—
Solution A,Solution B,Mobile phase,Blank solution,Standard stock solutions 1,2,and3,Standard solutions 1and2,Control solution,Chromatographic system,andProcedure— Proceed as directed for Related compounds,Test 1under Iodixanol.
Test solution 1— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 25mg of iodixanol per mL.
Test solution 2— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 2.5mg of iodixanol per mL.
TEST2—
Solution A,Solution B,Mobile phase,Blank solution,Standard stock solutions 1,2,and3,Standard solutions 1,2,and3,andChromatographic system— Proceed as directed for Related compounds,Test 2under Iodixanol.
Test solution— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 2.5mg of iodixanol per mL.
Procedure— Proceed as directed for Related compounds,Test 2under Iodixanol.Not more than 0.3%of iodixanol related compound Eis found;and not more than 0.6%of impurity 4is found.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer about 2mLof the Injection to a glass-stoppered,125-mLconical flask,add 50mLof 5%sodium hydroxide solution and 1.0g of powdered zinc,connect the flask to a reflux condenser,and reflux for 1hour.Cool the flask to room temperature,and rinse the condenser with 20mLof water,adding the rinsing to the refluxed solution.Filter the mixture,rinsing the flask and the filter with several small portions of water,and adding the filtered rinsings to the filtrate.Add 20mLof glacial acetic acid,dilute with water to 200.0mL,transfer 100.0mLof this solution to a 250-mLconical flask,and titrate with 0.1Nsilver nitrate VSusing autotitration,determining the endpoint potentiometrically.Each mLof 0.1Nsilver nitrate is equivalent to 25.84mg of iodixanol (C35H44I6N6O15).[NOTE—The result must be corrected for any inorganic halides that may be present due to added stabilizers or buffers.]
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1042
Pharmacopeial Forum:Volume No.29(1)Page 80
Phone Number:1-301-816-8305