Printed on: Tue Jul 20 2021, 06:32:25 PM Official Status: Currently Official on 20-Jul-2021 DocId: 1_GUID-F4BF2536-5419-4200-B1AB-2F875E334875_3_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official as of 01-May-2018 Document Type: USP @2021 USPC
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of 2 N sulfuric acid and 1.0 mL of toluene, shake, and allow

Iopamidol Injection the layers to separate: the toluene layer shows no red color.
Limit of free iodide—Transfer 10.0 mL of Injection to a
» Iopamidol Injection is a sterile solution of beaker, add 40 mL of water, and mix. Proceed as directed in
the Limit of free iodide test under Iopamidol beginning with
Iopamidol in Water for Injection. It contains not less “add 2.0 mL of 0.001 M potassium iodide.” Not more than
than 95.0 percent and not more than 105.0 3.1 mL of 0.001 N silver nitrate is required (0.04 mg of iodide
percent of the labeled amount of iopamidol per mL).
(C17H22I3N3O8). It may contain small amounts of Other requirements—It meets the requirements under
Injections and Implanted Drug Products á1ñ.
suitable buffers and of Edetate Calcium Disodium
as a stabilizer. Iopamidol Injection intended for Assay—
intravascular or intrathecal use contains no Solution A—Use water.
Solution B—Prepare a filtered and degassed mixture of
antimicrobial agents. water and methanol (3:1).
Mobile phase—Use variable mixtures of Solution A and
Packaging and storage—Preserve Injection intended for Solution B as directed for Chromatographic system. Make
intravascular or intrathecal use in single-dose containers, adjustments if necessary (see System Suitability under
preferably of Type I glass, and protected from light. Chromatography á621ñ).
Labeling—Label containers of Injection to direct the user to Resolution solution—Transfer 10.0 mg of USP Iopamidol
discard any unused portion remaining in the container and to Related Compound B RS and 10.0 mg of USP Iopamidol RS
check for the presence of particulate matter before using. to a 1000-mL volumetric flask. Dissolve in and dilute with
Label it also to state its routes of administration. water to volume, and mix.

al
USP Reference standards á11ñ— Standard preparation—Dissolve about 20 mg of USP
USP Iopamidol RS Iopamidol RS, accurately weighed, in about 10 mL of water,
USP Iopamidol Related Compound A RS and dilute quantitatively and stepwise with water to obtain a
N,N′-Bis-(1,3-dihydroxy-2-propyl)-5-amino-2,4,6- solution having a known concentration of about 80 µg of USP
triiodoisophthalamide. Iopamidol RS per mL.
C14H18I3N3O6 705.03
USP Iopamidol Related Compound B RS
5-Glycolamido-N,N′-bis[2-hydroxy-1-(hydroxymeth yl)
ethyl]-2,4,6-triiodoisophthalamide.
ci Assay preparation—Dilute an accurately measured volume
of Injection, equivalent to about 1000 mg of iopamidol,
quantitatively and stepwise with water to obtain a solution
having a concentration of about 80 µg of iopamidol per mL.
C16H20I3N3O7 747.07 Chromatographic system (see Chromatography á621ñ)—The
ffi
Identification— liquid chromatograph is equipped with a 240-nm detector
A: Evaporate a volume of Injection, equivalent to about and a 4.6-mm × 25-cm stainless steel column that contains
500 mg of iopamidol, to dryness, and heat the residue so 5-µm packing L1. The column temperature is maintained at
obtained in a suitable crucible: violet vapors are evolved. 35°, and the flow rate is about 1.5 mL per minute. The
B: It responds to the Thin-Layer Chromatographic chromatograph is programmed to provide variable mixtures
Identification Test á201ñ, the test solution and the Standard of Solution A and Solution B, the percentage of Solution B being
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solution being prepared at a concentration of 0.5 mg per mL 8.0% at the time of injection, and is held at that percentage
in a mixture of methanol and water (9:1), the solvent mixture for 6 minutes, then increased linearly to 35.0% at 18 minutes,
being chloroform, methanol, ammonium hydroxide, and after which it is changed to increase linearly to 92.0% at 30
water (60:30:9:1), and short-wavelength UV light being used minutes, maintained at that percentage for 4 minutes, and
to locate the spots. decreased linearly to 8.0% at 36 minutes, where it is held to
Bacterial Endotoxins Test á85ñ —It contains not more than the end of the run at 40 minutes. Chromatograph the
0.6 USP Endotoxin Unit per mg of iodine. Resolution solution, and record the peak responses as directed
pH á791ñ: between 6.5 and 7.5. for Procedure: the resolution, R, between iopamidol related
Particulate Matter in Injections á788ñ —The Injection compound B and iopamidol is not less than 7.
labeled for intrathecal use meets the requirements for Procedure—Separately inject equal volumes (about 20 µL)
small-volume injections. of the Standard preparation and the Assay preparation into the
Free aromatic amine—Transfer an accurately measured chromatograph, record the chromatograms, and measure the
volume of Injection, equivalent to about 500 mg of iopamidol, responses for the major peaks. Calculate the quantity, in mg,
to a 25-mL volumetric flask, dilute with water to 20 mL, and of iopamidol (C17H22I3N3O8) in the portion of Injection taken
mix. To a second 25-mL volumetric flask transfer 16 mL of by the formula:
water and 4.0 mL of Standard solution prepared by
dissolving a suitable quantity of USP Iopamidol Related 12.5C(r U/r S)
Compound A RS in water and diluting with water to obtain a
solution having a concentration of 62.5 µg per mL. Proceed as in which C is the concentration, in µg per mL, of USP
directed in the test for Free aromatic amine under Iopamidol, Iopamidol RS in the Standard preparation, and r U and r S are
beginning with “to the third 25-mL volumetric flask add 20 mL the peak responses obtained from the Assay preparation and
of water.” The absorbance of the solution from the iopamidol the Standard preparation, respectively.
is not greater than that of the Standard solution (0.05%).
Free iodine—Transfer a volume of Injection, equivalent to
2.0 g of iopamidol, to a glass-stoppered test tube. Add 2 mL

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