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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 14-Aug 23 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
not specified
Type of method:
flask method

Test material

Specific details on test material used for the study:
Test item name: E stage 3 intermediate

Chemical name: 3-[(2R)-2-amino-2-phenylethyl]-5-(2-fluoro-3-methoxyphenyl)-1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-6-methylpyrimidine-2,4(1H,3H)-dione 2-hydroxybenzoate (1:1)

CAS: 1821300-84-8

Purity: 97.4%

Batch no.: BO1801B009

Expiration date: 2019-02-05 (retest date)

Physical status: white powder

Storage conditions: Store at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
109.97 mg/L
Conc. based on:
test mat.
Incubation duration:
> 24 h
Temp.:
20 °C
pH:
5
Details on results:
The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).

Applicant's summary and conclusion

Conclusions:
The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).
Executive summary:

The water solubility of E stage 3 intermediate was determined compatible with the Principles of OECD Guidlines for testing of Chemicals No. 105 'Water Solubility'. Based on the test results, the water solubility was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).


 


The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).