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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:
11 September 1998 to 02 November 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to EU test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Constituent 1
Details on test material:
Test substance: T-9601
Batch: HI-295
Manufacturing date: May 29,1998
Purity: 94.7 %± 0.5% (w/w)
Certificate; NB 203, dated November 16, 1998
Expiry date: May 2001
Storage stability: 3 years, Exclusion of moisture, refrigerator (Information by the producer)

Results and discussion

Water solubility
Water solubility:
0.002 mg/L
Temp.:
20 °C
pH:
7
Details on results:
Individual Results

The coating check was successful.

According to the guideline, the data of the fractions 1 to 5 were not taken into account for the following evaluation. The following values for the water solubility were calculated from the fractions 6 to 60 for both columns.

Result run 1: Evaluation of the fractions 6 to 60. The water solubility varies between 0.0014 and 0.0022 mg/l. Average water solubility: 0.0019 mg/l (RSD: 14 %).

Result run 2: Evaluation of the fractions 6 to 60. The water solubility varies between 0.0014 and 0.0017 mg/l. Average water solubility: 0.0016mg/l (RSD: 6 %). The values for fractions 36-40 were seen as outlier and not considered.

The other fractions were not evaluated.

Any other information on results incl. tables

Column-elution method: Run 1 (applied standards: 0.04698 mg/l for fractions 6 to 30; average HPLC peak area: 0.914; 0.05020 mg/l for fractions 31 to 60; average HPLC peak area: 0.863)

Fraction

No.

V

(ml)

pH

HPLC peak area

cs

(mg/l)

6-10

99

6-21

0.842

0.00219

11-15

98

6.31

0.675

0.00177

16-20

96

6.39

0.528

0.00141

21-25

92

6.44

0.595

0.00166

26-30

96

6.53

0.566

0.00152

31-35

97

6.57

0.736

0.00221

36-40

96

6.57

0.635

0.00192

41-45

96

6.31

0.577

0.00175

46-50

96

6.21

0.601

0.00182

51-55

96

6.20

0.714

0.00216

56-60

96

6.21

0.643

0.00195

 

Column-elution method: Run 2 (applied standards: 0.0566 mg/l for fractions 6 to 35; average HPLC peak area: 0.965; 0.05116 mg/l for fractions 36 to 60; average HPLC peak area: 0.832). *The values for fractions 36-40 were seen as outlier and not considered.

Fraction

No.

V

(ml)

pH

HPLC peak area

cs

(mg/l)

6-10

92.0

6.42

0.518

0.00165

11-15

92.0

6.35

0.496

0.00158

16-20

92.0

6.32

0.535

0.00171

21-25

92.0

6.40

0.495

0.00158

26-30

92.0

6.31

0.499

0.00159

31-35

93.0

6.32

0.455

0.00144

36-40*

93.0

6.40

1.769

0.00585

41-45

92.0

6.33

0.453

0.00151

46-50

92.0

6.37

0.454

0.00152

51-55

92.0

6.31

0.446

0.00149

56-60

92.0

6.42

0.503

0.00168

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility cs of the test substance T-9601 (batch HI-295) at a temperature of 20 °C was determined as follows (average over both runs):
cs = 0.0017 mg/l
SD = 0.0002 mg/I
RSD = 11 %
Executive summary:

The objective of this study was the determination of the water solubility csof the test substance T-9601 (batch HI-295) according to guideline 92/69/EEC, appendix A.6. The study was conducted in compliance with the Principles ofGood Laboratory Practice(GLP).

 

The water solubility csof the test substance has been determined according to the "column-elution" method.

 

The water solubility csof the test substance at a temperature of 20 °C was determined as follows (average over both runs):

cs    = 0.0017 mg/l

SD   = 0.0002 mg/I

RSD = 11 %