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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:
July 1994 - February 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
70.59 g/L
Conc. based on:
test mat.
Incubation duration:
>= 18 - <= 43 h
Temp.:
20 °C
pH:
3.9
Remarks on result:
other: Mean value; Standard deviation (%) 1.2

Table 1. Water solubility determination.

Test No.

Pre-conditioning time

at 30ºC

(h)

Equilibration time

at 20ºC

(h)

pH

of saturated solution

Concentration of TS

in the saturated solution

(g/L)

1

2

18

3.9

70.86

2

2

24

3.9

72.26

3

2

43

3.9

69.58

4

4

18

3.9

69.87

5

4

24

3.9

70.31

6

4

43

3.9

70.65

Mean

70.59

SD (%)

1.2

Conclusions:
Water solubility: 70.59 g/L at 20 ºC and 3.9 pH.
Executive summary:

The flask procedure (EU Method A.6) was applied for the measurement of water solubility and the content of the test substance was determined by Ion Chromatography.

The water solubility of Fosfomycin PEA salt was 70.59 g/L at 20 ºC and 3.9 pH, with a standard deviation of 1.2 %.

Description of key information

Key study: Test method according to EU Method A.6. GLP study.

Key value for chemical safety assessment

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

Additional information

Key study: Test method according to EU Method A.6 (flask procedure). GLP study. The water solubility of Fosfomycin PEA salt was 70.59 g/L at 20 ºC and 3.9 pH, with a standard deviation of 1.2 %.