Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The experimental start date was 14 May 2019, and the experimental completion date was 16 May 2019.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EC Guideline A.6.
Version / remarks:
Water Solubility. March 04, 2016.
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
Water Solubility. July 27, 1995.
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
Water Solubility: Column
Elution Method; Shake Flask Method. March 1998.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Remarks:
Also flask method was used.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
White to off-white powder.
Storage Conditions: At room temperature.
Specific details on test material used for the study:
Batch (Lot) Number: 334115
Expiry date: 14 April 2020 (retest date)
Physical Description: White to off-white powder
Purity/Composition: 99.9%
Storage Conditions: At room temperature

Results and discussion

Water solubility
Water solubility:
ca. 9.66 mg/L
Conc. based on:
test mat.
Incubation duration:
ca. 25 h
Temp.:
20 °C
pH:
ca. 7.3
Remarks on result:
other:
Remarks:
loading of aqueous phase was between 10 and 200 mg/L

Any other information on results incl. tables

Preliminary Test

The content of test item dissolved in the water sample was 5.34 mg/L.

Main Study

The results for the samples taken at a flow rate set to 12 and 24 mL/h are given inTable 4.

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

Table 4          
Main study - water solubility of the test item

Flow rate

[mL/h]

Sample no.

Concentration analyzed

pH

Individual
[mg/L]

Mean1
[mg/L]

CV
[%]

Mean2
[mg/L]

MD
[%]

 

 

 

 

 

 

 

 

 

24

1

9.44

9.34

7.4

9.66

6.6

7.3

 

2

9.30

 

 

 

 

 

 

3

9.60

 

 

 

 

 

 

4

9.42

 

 

 

 

 

 

5

9.74

 

 

 

 

 

 

6

9.45

 

 

 

 

 

 

7

7.43

 

 

 

 

 

 

8

9.61

 

 

 

 

 

 

9

9.76

 

 

 

 

 

 

10

9.62

 

 

 

 

 

 

 

 

 

 

 

 

 

12

1

9.88

9.98

1.7

 

 

7.4

 

2

9.72

 

 

 

 

 

 

3

103

 

 

 

 

 

 

4

103

 

 

 

 

 

 

5

9.98

 

 

 

 

 

 

6

10.0

 

 

 

 

 

 

7

9.69

 

 

 

 

 

 

8

103

 

 

 

 

 

 

9

103

 

 

 

 

 

 

10

103

 

 

 

 

 

 

 

 

 

 

 

 

 

1  Mean of the concentrations obtained at one flow rate.

2    Mean of the concentrations obtained at both flow rates.

3     Obtained by extrapolation of the calibration curve.

Applicant's summary and conclusion

Conclusions:
The column elution method was applied for the determination of the water solubility of Maropitant base (CJ-11,972).
The water solubility of the test item at 20°C was 9.66 mg/L.
The pH of the aqueous samples was 7.3 and 7.4.