(2S)-3-Methyl-2-[N-({2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1-biphenyl]-4-yl}methyl)pentanamido]alkanoic acid

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sep - Oct 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

GLP compliance:

yes

Type of method:

column elution method

Key result

Water solubility:

10.7 mg/L

Conc. based on:

test mat. (dissolved fraction)

Temp.:

20 °C

pH:

3.8

Details on results:

The saturation concentration of CGP 48933 Step 9 was determined to be 11.3 mg/I± 0.6 mg/I standard deviation in the first experiment and 10.2 mg/I± 0.3 mg/I standard deviation in the second experiment.
The relativ standard... deviation of each 7 consecutive samples was calculated to be 3 - 5 % during the experiments. 1'he variation between the water solubilities as determined during the low flow rate (first experiment) and the high flow rate was calculated to be< 10 %. According to the guidelines, the criteria of< 30 % were met and therefore the test was considered to be valid.
The linearity of the analytical method was proved in the concentration range from 1.45 μg/ml to 14.5 μg/ml.

Solvent	Temp (°C)	Resulting pH	Solubility (g/L)
water	25	3.8	0.18
0.2 M NaCl	25	3.8	0.18
0.1 N HCl	22	1.12	0.084
0.01 M glycine buffer, pH = 3	22	3.05	0.104
0.067 M phosphate buffer, pH = 5.2	22	4.41	0.64
0.067 M phosphate buffer, pH = 6.0	22	4.90	2.82
0.067 M phosphate buffer, pH = 7.4	22	5.26	14.4
0.067 M phosphate buffer, pH = 8.0	22	5.29	16.8
water	37	3.8	0.21
0.01 N HCl	37	1.0	0.10

Conclusions:

The water solubility of CGP 48933 Step 9 was determined to be on avarage 10.7 mg/I at 20.0 °C ± 0.5 °C using the column elution method.

Description of key information

The water solubility of CGP 48933 Step 9 was determined to be on avarage 10.7 mg/L at 20.0 °C ± 0.5 °C using the column elution method.

Key value for chemical safety assessment

Water solubility:

10.7 mg/L

at the temperature of:

20 °C