5-(Acetyl-(3-(acetyl-(3,5-bis(2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl)amino)-2- hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide; 5,5'-((2-Hydroxytrimethylene)bis(acetylimino))bis(N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodoisophthalamide);

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with Good Laboratory Practices and Good Manufacturing Practices.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Guideline:

other: Technical Assistance Document 3.09, Environmental Assessment Technical Assistance Handbook issued by Food and Drug Administration, 1987

Principles of method if other than guideline:

The hydrolysis of Iodixanol was determined at pH 5, 7, 9 at 50oC for five days. Three samples of Iodixanol were stressed at each pH level. The stressed samples were analyzed by a reverse phase C-18 HPLC procedure. The mobile phase was a linear gradient of 3-17% acetonitrile in water for one hour at 1.0 mL/min.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Results and discussion

Transformation products:

no

Dissipation DT50 of parent compound

Key result

pH:

7

Remarks on result:

hydrolytically stable based on preliminary test

Any other information on results incl. tables

For each sample at each pH stressing level, there was no evidence of degradation products in the chromatograms. Also, recovery of intact Iodixanol in each sample was nearly 100%. Therefore, it is concluded that Iodixanol is not susceptible to hydrolisis from pH 5 to pH 9.

Applicant's summary and conclusion

Conclusions:

Iodixanol is not susceptible to hydrolysis and its rate constant is zero.