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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 - 09 Oct 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
March 2014
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
September 07, 1995
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
GLP compliance:
yes (incl. certificate)
Remarks:
National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India
Type of method:
flask method
Water solubility:
0.022 g/L
Temp.:
20 °C
pH:
7
Water solubility:
0.021 g/L
Temp.:
20 °C
pH:
5
Water solubility:
0.021 g/L
Temp.:
20 °C
pH:
9

Results of linearity check

The linearity of the method was established before analysing the sample. Five different concentrations of the test item reference standard solutions ranging from 5.05 to 40.02 mg/L were injected into HPLC in singlet. The peak area was plotted against concentration (mg/L). The correlation coefficient (r) was 0.999.

 

Accuracy (% Recovery) and Precision (% RSD)

The overall mean accuracy and the overall %RSD (based on three fortification level) were: 104.12 and 1.39 for pH-5 buffer solution, 104.98 and 0.43 for pH-7 buffer solution, 103.90 and 3.39 for pH-9 buffer solution.

 

Preliminary test results

Buffer Water

Weight (g) of Test Item

Solubility Observed in (mL of Buffer)

Approx. solubility (g/L)

 

 

Volume (mL) of buffer added

10

50

100

200

300

350

400

430

450

460

 

pH 5.0

0.01052

Solubility observed

N

N

N

N

N

N

N

N

Y

-

0.022

pH 7.0

0.01034

Solubility observed

N

N

N

N

N

N

N

N

N

Y

0.022

pH 9.0

0.01077

Solubility observed

N

N

N

N

N

N

N

N

N

Y

0.022

Y= yes, N= No

 

 

Water solubility results

The results of water solubility test for pH 5.0 buffer water are summarized in the following table:

Sample

Agitation Time

pH

Replication

Peak Area of Sample

Intercept with Y-axis

Slope of the Line

 Solubility (g/L)

Mean Solubility (g/L)

24 hours

5.00

I

379041

7230.40

17569.46

0.0212

0.0212

II

378973

0.0212

48 hours

5.02

I

377555

0.0211

0.0211

II

377171

0.0211

72 hours

5.02

I

377617

0.0211

0.0211

II

377432

0.0211

Overall Mean

0.0211

Standard Deviation

0.0001

Temperature = 20 °C

Dilution Factor = 1

 

The results of water solubility test for pH 7.0 buffer water are summarized in the following table:

Sample

Agitation Time

pH

Replication

Peak Area of Sample

Intercept with Y-axis

Slope of the Line

Solubility (g/L)

Mean Solubility (g/L)

24 hours

7.01

I

395760

7230.40

17569.46

0.0221

0.0221

II

395371

0.0221

48 hours

7.02

I

392492

0.0219

0.0219

II

392564

0.0219

72 hours

7.01

I

393748

0.0220

0.0220

II

393617

0.0220

Overall Mean

0.0220

Standard Deviation

0.0001

Temperature = 20 °C

Dilution Factor = 1

 

The results of water solubility test for pH 9.0 buffer water are summarized in the following table:

Sample

Agitation Time

pH

Replication

Peak Area of Sample

Intercept with Y-axis

Slope of the Line

Solubility (g/L)

Mean Solubility (g/L)

24 hours

9.01

I

364888

7230.40

17569.46

0.0204

0.0204

II

365283

0.0204

 

48 hours

9.02

I

367199

0.0205

0.0205

II

367140

0.0205

 

72 hours

9.00

I

368558

0.0206

0.0206

II

368652

0.0206

 

Overall Mean

0.0205

Standard Deviation

0.0001

Description of key information

OECD guideline, GLP-compliant study available. Water solubility was determined using flask method. Water solubility was 0.022g/L at 20 °C.

Key value for chemical safety assessment

Water solubility:
22 mg/L
at the temperature of:
20 °C

Additional information