U.S. PHARMACOPEIA

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Iodixanol Injection
» Iodixanol Injection is a sterile solution of Iodixanol in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent 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 I glass, protected from light, or in plastic containers.
Identification—
A: Evaporate 1 mL of 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 solution correspond to those in the chromatogram of Standard solution 2, as obtained in Chromatographic purity, Test 2.
Bacterial endotoxins 85: not more than 0.2 USP Endotoxin Unit per 50 mg of iodine.
pH 791: between 6.8 and 7.7.
Osmolarity 785: between 270 and 310 mOsmol per kg.
Limit of free iodide— Transfer 5.0 mL of Injection to a suitable container, add 2.0 mL of acetic acid solution and about 30 mL of water, and titrate with 0.001 N silver nitrate VS, determining the endpoint potentiometrically. Each mL of 0.001 N silver nitrate is equivalent to 0.1269 mg of iodine. Not more than 15.0 mL of 0.001 N silver nitrate is required: not more than 20 mg of iodide per g is found.
Related compounds—
TEST 1—
Solution A, Solution B, Mobile phase, Blank solution, Standard stock solutions 1, 2, and 3, Standard solutions 1 and 2, Control solution, Chromatographic system, and Procedure— Proceed as directed for Related compounds, Test 1 under Iodixanol.
Test solution 1— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 25 mg of iodixanol per mL.
Test solution 2— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 2.5 mg of iodixanol per mL.
TEST 2—
Solution A, Solution B, Mobile phase, Blank solution, Standard stock solutions 1, 2, and 3, Standard solutions 1, 2, and 3, and Chromatographic system— Proceed as directed for Related compounds, Test 2 under Iodixanol.
Test solution— Quantitatively dilute a volume of Injection with water to obtain a solution containing about 2.5 mg of iodixanol per mL.
Procedure— Proceed as directed for Related compounds, Test 2 under Iodixanol. Not more than 0.3% of iodixanol related compound E is found; and not more than 0.6% of impurity 4 is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer about 2 mL of the Injection to a glass-stoppered, 125-mL conical flask, add 50 mL of 5% sodium hydroxide solution and 1.0 g of powdered zinc, connect the flask to a reflux condenser, and reflux for 1 hour. Cool the flask to room temperature, and rinse the condenser with 20 mL of 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 20 mL of glacial acetic acid, dilute with water to 200.0 mL, transfer 100.0 mL of this solution to a 250-mL conical flask, and titrate with 0.1 N silver nitrate VS using autotitration, determining the endpoint potentiometrically. Each mL of 0.1 N silver nitrate is equivalent to 25.84 mg 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 : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1156
Pharmacopeial Forum : Volume No. 29(1) Page 80
Phone Number : 1-301-816-8305