Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 February 2018 to May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Deviations:
no
GLP compliance:
yes
Type of method:
air comparison pycnometer (for solids)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
New Zealand Pharmaceuticals, 68 Weld Street, Palmerston North 4472, New Zealand (Batch No. 2216242)
- Expiration date of the lot/batch:
07 November 2021
- Purity:
91.2 % (07 November 2016)

Results and discussion

Density
Key result
Type:
relative density
Density:
1.259 other: g/mL
Temp.:
20 °C

Applicant's summary and conclusion

Conclusions:
The density of the test item obtained was 1.2587 g/mL with 0.40 % RSD.
Executive summary:

In an OECD 109 Guideline study, the relative density of the test substance, Special Bile (Bile, Hydrolyzates), was determined. The density of the test item obtained was 1.2587 g/mL with 0.40 % RSD.