4-O-α-D-glucopyranosyl-D-glucitol

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 February 2018 to 09 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

version 2014

Deviations:

yes

Remarks:

the temperature during the agitation at 30°C of the test item was not registered. This deviation was not considered to have affected the quality or the interpretation of the results obtained.

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

Version 1995

Deviations:

yes

Remarks:

the temperature during the agitation at 30°C of the test item was not registered. This deviation was not considered to have affected the quality or the interpretation of the results obtained.

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Specific details on test material used for the study:

Identification : MALTITOL
CAS No. : 585-88-6
EC No. : 209-567-0
Batch ELEL7
Appearance White powder

Key result

Water solubility:

738 g/L

Conc. based on:

act. ingr. (dissolved fraction)

Loading of aqueous phase:

2 000 g/L

Incubation duration:

>= 24 - <= 72 h

Temp.:

20 °C

pH:

6.7

Details on results:

Calibration curve : R = 0.9987
A = 0.996 x C + 0.626

 

	Reference of test solutions	Peak area (area units)	Mean peak area (area units)	Conc. (mg/L)	Dilution factor	Final conc. in maltitol (mg/L)	Final conc. in maltitol (g/L)
			A	B	Df	Cf	Cf1
After 24h	18-078 1Bdil	1.3932	1.3861	0.763	1000000	763350	763.4
	18-078 1Bdil	1.3790
	18-078 1Cdil	1.3807	1.3810	0.758	1000000	758179	758.2
	18-078 1Cdil	1.3812
After 48h	18-078 1Ddil	1.3660	1.3544	0.731	1000000	731468	731.5
	18-078 1Ddil	1.3427
	18-078 1Edil	1.3265	1.3331	0.710	1000000	710080	710.1
	18-078 1Edil	1.3396
After 72h	18-078 1Fdil	1.3429	1.3504	0.727	1000000	727452	727.5
	18-078 1Fdil	1.3578
	18-078 1Gdil	1.3561	1.3575	0.735	1000000	734581	734.6
	18-078 1Gdil	1.3588
						Mean	738
						SD	20
						RSD (%)	2.71

 

Conclusions:

The water solubility of the maltitol is 738 g/L at 20°C and pH 6.7.

Executive summary:

The water solubility of maltitol was determinated according to the EU method A.6 and OECD 105 and in compliance with the GLP.

The shake flask method was used and in a preliminary test based on visual observations the solubility was found between 200 and 1000 g/L.

In the main study a suspension of 2000gr/L was prepared in 6 glass vessels. The flasks were sealed and subjected to magnetical stirring into a water bath at about 30 °C.

Two solutions were removed after 24 h, 48 h and 72 hours of stirring. After a minimum of 24 hours at 20.0 °C ± 2.0 °C, an aliquot was centrifuged at 7000 rpm for 10 minutes, filtered on 0.45 μm filter 1000 times with water and then diluted again 1000 times with water before analysis by ionic chromatography using amperometric detection. The analysis method was demonstrated to satisfy the SANCO/3030/99 rev.4 regarding the specificity, linearity, accuracy and prcision (Report 18 -918023 -004).

The water solubility of maltitol at 20°C and pH 6.7 is equal to 738 ± 20 g/L ( relative standard deviation 2.71%).

The water solubility study is classified as acceptable, and satisfies the guideline requirements of the EU method A.6 and OECD 105.

Description of key information

The water solubility of the maltitol is 738 g/L at 20°C and pH 6.7.

Key value for chemical safety assessment

Water solubility:

738 g/L

at the temperature of:

20 °C

Additional information

The water solubility of maltitol was determinated according to the EU method A.6 and OECD 105 and in compliance with the GLP.

The shake flask method was used and in a preliminary test based on visual observations the solubility was found between 200 and 1000 g/L. In the main study a suspension of 2000gr/L was prepared in 6 glass vessels. The flasks were sealed and subjected to magnetical stirring into a water bath at about 30 °C. Two solutions were removed after 24 h, 48 h and 72 hours of stirring. After a minimum of 24 hours at 20.0 °C ± 2.0 °C, an aliquot was centrifuged at 7000 rpm for 10 minutes, filtered on 0.45 μm filter 1000 times with water and then diluted again 1000 times with water before analysis by ionic chromatography using amperometric detection. The analysis method was demonstrated to satisfy the SANCO/3030/99 rev.4, regarding the specificity, linearity, accuracy and prcision (Report 18 -918023 -004).

The water solubility of maltitol at 20°C and pH 6.7 is equal to 738 ± 20 g/L (relative standard deviation 2.71%).