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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 31, 2017 - April 11, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: yes
Key result
Water solubility:
ca. 20.45 g/L
Conc. based on:
test mat.
Incubation duration:
> 1 - < 3 d
Temp.:
20 °C
pH:
>= 3.08 - <= 3.09
Details on results:
The individual results from each of three flasks, which should not differ by more than 15%, are averaged. If the concentrations measured in at least the two last samples do not differ by more than 15% the test is satisfactory.

Table 1. Results of the preliminary test

0.1g in x mL of solution

0.1

0.5

1

2

10

Soluble (+/-)

-

-

-

-

+

Approximate solubility, g/L

> 1000

1000 to 200

200 to 100

100 to 50

50 to 10

     x – water of pH 5.6 

Table 2. Study solution in water

Sample

day/ flask

Weight

of the sample

[mg]

Dilution

[mL]

Cp

[mg/mL]

Peak area

Average peak area

Ap

X

[g/kg]

1

1

99.25

25-1-25

0.1588

293850

293121

293485.5

21.663

2

98.65

0.1578

289483

289806

289644.5

21.510

2

3

99.05

25-1-25

0.1585

259545

260436

259990.5

19.23

4

98.25

0.1572

256396

256589

256492.5

19.13

3

5

101.95

25-1-25

0.1631

286591

286608

286599.5

20.595

6

100.95

0.1615

283371

283212

283291.5

20.558

Table 3. Results ofCytidine 3'-(dihydrogen phosphate)solubility in water

Mixing timeat 30 ºC [days, flasks]

1

2

3

Samples

1

2

3

4

5

6

Temperature, ºC

20.1

20.1

20.2

pH

3.09

3.08

3.08

Concentration of Cytidine 3'-(dihydrogen phosphate), g/kg

21.66

21.51

19.23

19.13

20.60

20.56

Average concentration of Cytidine 3'-(dihydrogen phosphate),g/kg

21.59

19.18

20.58

Average concentrationof Cytidine 3'-(dihydrogen phosphate), g/kg

20.45

The solubility of Cytidine 3'-(dihydrogen phosphate) in wateris 20.45 g/kg. The density of this solution is about 1kg/L (about water density). After recalculation:

 

The solubility of Cytidine 3'-(dihydrogen phosphate) in water

 is 20.45 g/L

Conclusions:
The solubility of the test item at 20 ± 0.5 ºC and at pH ranging from 3.08 to 3.09 is 20.45 g/L.
Executive summary:

The study of the determination of test item solubility in water at one pH value using shake flask method was performed according to OECD 106 and EU method A.6, following GLP. The test item content in obtained samples for study of the solubility in the water at one pH value was determined by HPLC method, using a liquid chromatograph Spectra-Physics P-200. The solubility of the test item at 20 ± 0.5 ºC and at pH ranging from 3.08 to 3.09 is 20.45 g/L.

Description of key information

Key study: OECD 105 and EU method A.6. GLP study. The solubility of the test item at 20 ± 0.5 ºC and at pH ranging from 3.08 to 3.09 is 20.45 g/L.

Key value for chemical safety assessment

Water solubility:
20.45 g/L
at the temperature of:
20 °C

Additional information

Key study: The study of the determination of test item solubility in water at one pH value using shake flask method was performed according to OECD 106 and EU method A.6, following GLP. The test item content in obtained samples for study of the solubility in the water at one pH value was determined by HPLC method, using a liquid chromatograph Spectra-Physics P-200. The solubility of the test item at 20 ± 0.5 ºC and at pH ranging from 3.08 to 3.09 is 20.45 g/L.