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);

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

January-December 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Principles of method if other than guideline:

Aqueous and methanol solutions of iodixanol were prepared and stored in 2 ml volumetric flasks with a plastic stopper. The bottles were inspected visually during 10 months.

GLP compliance:

not specified

Type of method:

flask method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Results and discussion

Water solubility

Water solubility:

> 1 other: g/mL

Temp.:

4 °C

pH:

> 5 - < 7

Any other information on results incl. tables

The solubility of iodixanol in water is more than 1g/ml at 4^oC and at room temperature. The experiment was performed January-December 1986.

Performance: Solution of iodixanol was prepared in 2ml volumetric flsk with a plastic stopper. The bottles were inspected visually during 10 months. Concentration, storage conditions and results are given in Table 1.

Solvent	Concentration w/v %	Temperature ^oC	Visual inspection
Water	60	4	Clear solution
Water	70	4	Clear solution
Water	100	4	Clear solution
Water	100	RT	Clear solution

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): soluble (1000-10000 mg/L)