L-aspartic acid, sodium salt

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

sodium 2-amino-3-carboxypropanoate

Cas Number:

323194-76-9

Molecular formula:

C4H7NO4.xNa

IUPAC Name:

sodium 2-amino-3-carboxypropanoate

Test material form:

solid: particulate/powder

Details on test material:

Name: L-aspartic acid, sodium salt monohydrate 1
Batch/Lot number: Z201125/ VG29848563
CAS number: 323194-76-9
Anhydrous substance name: L-aspartic acid, sodium salt, CAS: 17090-93-6
Appearance: Solid, white, crystalline powder
Purity: 98%
Expiry date: 24 November 2022
Storage conditions: Room temperature (15-25 ºC), protected from humidity (tight closed
container)

Results and discussion

Water solubility

Key result

Water solubility:

ca. 693.07 g/L

Conc. based on:

test mat.

Loading of aqueous phase:

0.521 g/L

Incubation duration:

ca. 3 d

Temp.:

20 °C

pH:

>= 7.08 - <= 7.09

Applicant's summary and conclusion

Conclusions:

Solubility in water of the Test item at 20.0 ± 0.5 oC and at pH ranging 7.08 – 7.09 is 693.07 g/l. (EC A.6./OECD 105)

Executive summary:

Solubility in water of the Test item at 20.0 ± 0.5 oC and at pH ranging 7.08 – 7.09 is 693.07 g/l. (EC A.6./OECD 105)

Description of the method

The study of the determination of ASPARTIC ACID SODIUM SALT MONOHYDRATE solubility in water at one pH value using shake flask method was carried out according to the method EC A.6. COUNCIL REGULATION (EC) No 440/2008 (Method A.6. Water solubility; p.57) and (EC) No 260/2014 (Method A.6. Water solubility; p.3) which is in conformity with OECD Guideline 105 and concluded in SPO/BS/08/b, edition 6.

3.5.2. Course of the study

The preliminary test of a small sample (~ 0.1g) of Test item was performed in a 10 ml measuring cylinder, in gradually increased volume of distilled water.  Starting from 0.1 g of water after addition of the sample, the solution was vigorously mixed for 10 minutes and it was visually determined if insoluble parts of Test item was in solution. In that way, an approximate solubility of Test item was determined at the solvent volume in which the whole substance was dissolved.

About 23 g of test item was weighed into each of three 50 ml glass vessels fitted with glass stoppers. 20 ml of double distilled water was added to each vessel. The volume of water was chosen on the basis of the analytical method and solubility range. 

These closed vessels were agitated in an incubator at 30 ^oC with magnetic stirrers.

After one day, one of the flasks was equilibrated for 24 h at the test temperature (20 ± 0.5) ^oC with occasional shaking. The other two flasks were treated similarly after initial equilibration at 30 ± 1 ^oC for two and three days, respectively.

The samples taken during saturation were separated using a vial-centrifuge to give the clear liquid phase and the concentration of test substance in the clear solvent phase was determined by a suitable HPLC method.

If the concentrations measured in at least the two last flasks did not differ by more than 15%, the test was satisfactory. If the results from vessels 1, 2 and 3 show a tendency of increasing values, the whole test should be repeated using longer equilibration times.

The pH of each sample was measured using a calibrated pH electrode (SPO/BS/24/t, edition 3).

The density of the solution was determined (SPO/BS/16/t, edition 2) to recalculate the analytical study results which were obtained in g/kg.