» Iohexol Injection is a sterile solution of Iohexol in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent 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 I glass, 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.
USP Reference standards 11
USP Iohexol RS.
USP Iohexol Related Compound A RS.
USP Iohexol Related Compound B RS.
USP Iohexol Related Compound C RS.
USP Endotoxin RS.
A: Evaporate 1 mL of 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 10 mg per mL. The test solution responds to the Thin-layer Chromatographic Identification Test 201, the Standard solution being prepared at a concentration of 10 mg of USP Iohexol RS per mL in methanol, the solvent mixture being a mixture of n-butyl alcohol, water, and glacial acetic acid (50:25:11), and short-wavelength UV light being used to locate the spots.
Bacterial endotoxins 85 It contains not more than 0.2 USP Endotoxin Unit per 50 mg of iodine.
pH 791: between 6.8 and 7.7.
Particulate matter 788 The Injection labeled for intrathecal use meets the requirements for small-volume injections.
Free iodide Transfer 5.0 mL of Injection to a suitable container, add about 20 mL of water, and titrate with 0.001 N silver nitrate VS determining the endpoint potentiometrically using a silver electrode in combination with an appropriate reference electrode. Each mL of 0.001 N silver nitrate is equivalent to 0.1269 mg of I (not more than 0.02%, based on the content of iohexol).
Other requirements It meets the requirements under Injections 1, and meets the requirements for Heavy metals and Related compounds under Iohexol.
Assay for iodine Transfer an accurately measured volume of Injection, equivalent to about 300 mg of iodine, to a glass-stoppered, 250-mL conical flask. Proceed as directed in the Assay under Iohexol, beginning with Add 25 mL of 1.25 N sodium hydroxide.
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USP32NF27 Page 2667Pharmacopeial Forum: Volume No. 28(2) Page 308