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);

Dissociation constant

Administrative data

Endpoint:

dissociation constant

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1992

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 3.04, Environmental Assessment Technical Assistance Handbook issued by Food and Drug Administration, 1987

Principles of method if other than guideline:

The dissociation constant of Iodixanol was determined using the potentiostatic titration technique. A 0.01 M solution of Iodixanol in water was titrated with 0.1N HCl at 0.1 ml increments. The pH of the solution was recorded after the addition of each increment of HCl.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Results and discussion

Dissociating properties:

no

Any other information on results incl. tables

Upon plotting volume of HCl versus pH, there was no evidence of the traditional S-shape titration curve. Also the pH values at each increment were nearly identical to the pH blank. A 0.01 M solution of Iodixanol in water was also titrated with 0.1N NaOH at 0.1 ml increments. The pH of the solutionswas recorded after addition of each increment of NaOH. Again, there was no evidence of the tradition S-shape titration curve, and again the pH values at the same increment were nearly identical to the ph values at the same increments for the titration of water blank.

Applicant's summary and conclusion

Conclusions:

Iodixanol does not dissociate.