C10H11I2NO3 447.01

1(4H)-Pyridineacetic acid, 3,5-diiodo-4-oxo-, propyl ester.
Propyl 3,5-diiodo-4-oxo-1(4H)pyridineacetate [587-61-1].

Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.

Identification—

Melting range 741: between 187 and 190.

Acidity— Dissolve 1.0 g in 40 mL of hot n-propyl alcohol previously neutralized to phenolphthalein TS, cool, and allow to stand in an ice bath for 15 minutes with frequent shaking. Filter, wash the residue with neutralized n-propyl alcohol, combine the filtrate and washings, add phenolphthalein TS, and titrate with 0.050 N sodium hydroxide to a pink color that persists for 15 seconds: not more than 0.15 mL of 0.050 N sodium hydroxide is required for neutralization.

Loss on drying 731— Dry it at 105 to constant weight: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.1%.

Iodine and iodide— Shake 2.4 g with 30 mL of water for 15 minutes, filter, and to 10 mL of filtrate add 1 mL of 2 N nitric acid, 1 mL of sodium nitrite solution (1 in 500), and 2 mL of chloroform. Shake, and centrifuge: any purple color in the chloroform layer is not darker than that obtained with a mixture of 6 mL of water and 4 mL of potassium iodide solution (2.6 in 100,000) treated in the same manner (0.01% of I).

Heavy metals, Method II 231: 0.002%.

Residual solvents 467: meets the requirements.

Assay— Using about 15 mg of Propyliodone, accurately weighed, proceed as directed in the Assay under Iodoquinol. Each mL of 0.02 N sodium thiosulfate is equivalent to 0.7450 mg of C10H11I2NO3.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 1851

Phone Number : 1-301-816-8305