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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 March - 18 June 1996
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EC Directive 92/69/EEC, Method A6 (flask stirring method).
Principles of method if other than guideline:
Distilled water_(SO ml) and test substance (ca 0.1 g) were combined in each of six conical flasks. The flasks were firmly stoppered and the contents stirred at 30°C ± 0.5°C prior to equilibration at the test temperature of20°C ± 0.5°C.

The contents of the flasks were stirred for the following times:

Test Pre-equilibration at 30°C Equilibration at 20°C
IA, IB 3 days 1 day
2A,2B 2 days I day
3A,3B 1 day 1 day

A blank of distilled water was run concurrently with all the tests.
GLP compliance:
yes
Type of method:
flask method

Test material

Constituent 1
Chemical structure
Reference substance name:
6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
EC Number:
421-320-0
EC Name:
6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one
Cas Number:
118289-55-7
Molecular formula:
Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O
IUPAC Name:
6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Intended use:Pharmaceutical intermediate
Purity:99.9%
Date received: 2 February 1996

Results and discussion

Water solubility
Water solubility:
3.84 mg/L
Temp.:
20 °C
Remarks on result:
other: pH Data was not available
Details on results:
No peaks were observed at the characteristic retention volume of the test substance in the blank solutions, showing that the analytical procedure was free from interferences

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of CP-89,575 has been determined as:

3.84 X 10"3 g/1 at 20°C