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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:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
3 319 mg/L
Temp.:
10 °C
pH:
2.2
Key result
Water solubility:
4 356 mg/L
Temp.:
20 °C
pH:
2.1
Details on results:
The temperature of the water bath was 10.0 °C respectively 20.0 °C.
The pH of the solutions were 2.2 at 10 °C and 2.1 at 20 °C.
The difference between the concentrations of the test substance of day 1 to 3 at 10 °C
and 20 °C was <15 % and the concentrations of the test substance showed no relevant tendency. Therefore the mean of day 1 - 3 was taken as the solubility of the test substance at both temperatures, according to the guidelines.
The water solubility of "TAZOBACTAM ACID" was determined to:
Mean: 3319 g/L, standard deviation: 0.020, replicates of three days, temperature 10.0 °C.
Mean: 4356 g/L, standard deviation: 0.082, replicates of three days, temperature 20.0 °C.
As the temperature coefficient of the solubility of the test substance was <3 % per °C, the solubility was not determined at three temperatures, in agreement with the guideline.

Table 1:          Water Solubility at 10 °C

Mass concentration of "TAZOBACTAM ACID" determined at different times of stirring, two solutions were used.

nominal temperature

equilibration time

pH of the solutions

concentration (mg/L)

deviation from the maximum concentration
(%)

1st

2nd

1st

2nd

mean

10 °C

1 day

2.2

2.2

3401

3283

3342

0.0

2 days

2.2

2.2

3369

3234

3302

-1.2

3 days

2.2

2.2

3384

3246

3315

-0.8

mean (day 1-3)

3319

SD

20

Table 2:          Water Solubility at 20 °C

Mass concentration of "TAZOBACTAM ACID" determined at different times of stirring, two solutions were used.

nominal temperature

equilibration time

pH of the solutions

concentration (mg/L)

deviation from the maximum concentration
(%)

1st

2nd

1st

2nd

mean

20 °C

1 day

2.1

2.1

4302

4302

4302

-3.3

2 days

2.1

2.1

4398

4235

4316

-3.0

3 days

2.1

2.1

4497

4404

4451

0.0

mean (day 1-3)

4356

SD

82

Conclusions:
The water solubility of "TAZOBACTAM ACID" was determined to:
Mean: 3.319 g/L, standard deviation: 0.020, replicates of three days, temperature 10.0 °C.
Mean: 4.356 g/L, standard deviation: 0.082, replicates of three days, temperature 20.0 °C.
The pH of the solutions were 2.2 at 10 °C and 2.1 at 20 °C.
Executive summary:

The water solubility of the test substance was determined by the flask method according to OECD- and EU-methods. The test substance was analysed by HPLC.

The water solubility of "TAZOBACTAM ACID" was determined to:

Mean: 3.319 g/L, standard deviation: 0.020, replicates of three days, temperature 10.0 °C.

Mean: 4.356 g/L, standard deviation: 0.082, replicates of three days, temperature 20.0 °C.

The pH of the solutions were 2.2 at 10 °C and 2.1 at 20 °C.

Description of key information

Key study. Test method according to OECD 105. GLP study.The test substance was analysed by HPLC. The water solubility of "TAZOBACTAM ACID" was determined to:

Mean: 3.319 g/L, standard deviation: 0.020, replicates of three days, temperature 10.0 °C.

Mean: 4.356 g/L, standard deviation: 0.082, replicates of three days, temperature 20.0 °C.

The pH of the solutions were 2.2 at 10 °C and 2.1 at 20 °C.

Key value for chemical safety assessment

Water solubility:
4 356 g/L
at the temperature of:
20 °C

Additional information