Diosmin

Water solubility

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 10th to May 18th, 2016.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

column elution method

Key result

Water solubility:

0.019 mg/L

Conc. based on:

test mat.

Incubation duration:

72 h

Temp.:

20 °C

pH:

>= 6.04 - <= 6.08

Details on results:

Solubility of the test item in distilled water is 0.019 ± 0.005 mg/L at pH = 6.04 - 6.08.

Table 1. Results of the preliminary test

0.01 g in x mL of water	0.05	0.1	0.2	1	10	100	200	1000	>1000
Soluble (+/-)	-	-	-	-	-	-	-	-	+
Approximate solubility, g/L	> 200	200 to 100	100 to 50	50 to 10	10 to 1	1 to 0.1	0.1 to 0.05	0.05 to 0.01	< 0.01

The final approximate solubility was found to be < 0.01 g/L.

 

Table 2. Study solution – first run.

Sample	Sample volume	Absorbance Ap	X [mg/L]
1	15	0.009	0.0160
2	6	0.005	0.0212
3	10	0.009	0.0240
4	18	0.016	0.0243
5	15	0.014	0.0254

Table 3. Study solution – second run.

Sample	Sample volume	Absorbance Ap	[mg/L] X
1	15	0.010	0.0179
2	15	0.008	0.0141
3	15	0.007	0.0122
4	15	0.008	0.0141
6	15	0.009	0.0160

Table 4. Results of Diosmin solubility at 20 ± 0.5 ºC in distilled water, column elution with recirculating pump method.

Concentration of test item, mg/L						Average concentration of test item, mg/L
	1	2	3	4	5	Successive runs	Total average
1 run	0.016	0.021	0.024	0.024	0.025	0.022 ± 0.004	0.019 ± 0.005
pH	6.06	6.05	6.07	6.04	6.08
2 run	0.018	0.014	0.012	0.014	0.016	0.015 ± 0.002
pH	6.05	6.05	6.07	6.08	6.05

Conclusions:

Solubility of the test item at 20 ± 0.5 ºC and at pH ranging 6.04 - 6.08 in water is 0.019 ± 0.005 mg/L.

Executive summary:

The study of the water solubility of the test item was performed by the column elution method, according to OECD 105 / EU Method A.6 (GLP study). The test item was dissolved in acetone and added to inert support material. Then, the solvent was evaporated, and the loaded support material was soaked for 2h in 5 ml of water. This suspension was added to a micro-column and the test item was eluted until the concentration reached a plateau. The mass concentration of the eluate at this time was determined by UV-VIS spectrophotometry, and taken as the water solubility value. Based on the test results, the solubility of the test item in water was found to be 0.019 ± 0.005 mg/L, at 20 ± 0.5 ºC and at pH 6.04 - 6.08.

Reference 2

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

Data from peer reviewed handbook. No information provided on the method.

GLP compliance:

not specified

Type of method:

other: not specified.

Key result

Remarks on result:

other: Practically insoluble.

Conclusions:

According to peer reviewed handbook data, diosmin monohydrate is practically insoluble in water.

Executive summary:

The Merck Index, 14th Ed (Handbook, peer-reviewed) states that diosmin monohydrate is practically insoluble in water.

Description of key information

Key study. Method according to OECD 105 / EU Method A.6 (column elution method), GLP study. The solubility of the test item in water was found to be 0.019 ± 0.005 mg/L, at 20 ± 0.5 ºC and at pH 6.04 - 6.08.

Key value for chemical safety assessment

Water solubility:

0.019 mg/L

at the temperature of:

20 °C

Additional information

Key study. The study of the water solubility of the test item was performed by the column elution method, according to OECD 105 / EU Method A.6 (GLP study). The test item was dissolved in acetone and added to inert support material. Then, the solvent was evaporated, and the loaded support material was soaked for 2h in 5 ml of water. This suspension was added to a micro-column and the test item was eluted until the concentration reached a plateau. The mass concentration of the eluate at this time was determined by UV-VIS spectrophotometry, and taken as the water solubility value. Based on the test results, the solubility of the test item in water was found to be0.019 ± 0.005 mg/L, at 20 ± 0.5 ºC and at pH 6.04 - 6.08. Supporting information from a peer-reviewed handbook states that the test item is practically insoluble in water.