Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
density
Remarks:
density
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 3.07, Environmental Assessment Technical Assistance Handbook issued by Food and Drug Administration, 1987
Principles of method if other than guideline:
The density of the Iodixanol was determined by wide-mouth pycnometer technique. This technique consist of placing Iodixanol in a containing of which the capacity is accurately known and which may be completely filled with liquid. The difference in weight when filled and when empty , along with the known volume of liquid, gives the density. For this experiment, hexane (20C) was used as the immersion liquid since Iodixanol is freely soluble in water.
GLP compliance:
yes
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Density
Key result
Type:
density
Density:
2.08 g/cm³
Temp.:
20 °C

Applicant's summary and conclusion

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