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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:
2017-01-31 to 2017-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-7982559-AAA (T001329)
- Physical state: solid (powder)
- Appearance: Grey-brown powder
Specific details on test material used for the study:
- Batch n°: I14IB3639
- Analytical purity: 97.9% (based on HPLC)
- Expiration date: 2020-09-17
- Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
0.562 mg/L
Conc. based on:
test mat. (dissolved fraction)
Remarks:
concentration analysed after centrifugation
Temp.:
20 °C
pH:
>= 7.5 - <= 8.2
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 0.621 mg/L. This value might be overestimating the water solubility as the centrifugation method was found not sufficient to remove all undissolved test item.

Main test
The results for the samples taken at 12 and 24 hours are given in the table in the next section.
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
No test item was detected in the samples from the blank column taken at a flow rate of 12 mL/h. A small response was observed in the samples from the blank column taken at a flow rate of 24 mL/h. This was probably caused by contamination since a similar response was observed in the analytical blank. As maximum contribution the samples is 0.35%, the study was not impacted.

Any other information on results incl. tables

The results for the samples taken at 12 and 24 hours are given in the table underneath.

 Flow rate (ml/h)  Mean concentration (mg/L)1  CV (%)  Mean (mg/L)2  MD (%)  pH
24   0.571  2.27 0.562  3.27  8.2
12  0.553  2.09    7.5

1: Mean of the concentrations obtained at one flow rate.

2: Mean of the concentrations obtained at both flow rates

Applicant's summary and conclusion

Conclusions:
The column elution method was applied for the determination of the water solubility of JNJ-7982559-AAA (T001329).
The water solubility of the test item at 20°C was 0.562 mg/L.
The pH of the aqueous samples was 7.5 – 8.2.