Registration Dossier

Diss Factsheets

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.