7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 29 January 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

yes

Remarks:

Since the water solubility value after the preliminary test proved to be less than 0.02 g/L, the flask method was not performed.

GLP compliance:

yes

Type of method:

other: Preliminary test

Specific details on test material used for the study:

- Batch No. of test material: FH20170302
- Manufacturing date of the batch: 02 March 2017
- Expiration date of the batch: 01 March 2019
- Appearance: Off-white tan powder
- Purity: 98.65%

Key result

Water solubility:

< 20 mg/L

Conc. based on:

test mat.

Temp.:

25 °C

Remarks on result:

other: Since the water solubility value after the preliminary test proved to be less than 0.02 g/L, the flask method was not performed and the final water solubility determination was not carried out.

Details on results:

SPECIFICITY AND IDENTIFICATION:
The method proved to be specific. The blank solutions did not interfere with the peak of the substance. The UV spectra of the analyte in the sample solution confirmed the presence of Formononetin.

LOD/LOQ:
The estimated LOD was 0.03 µg/mL and the instrumental LOQ was 0.10 µg/mL.

LINEARITY:
All acceptance criteria (R > 0.99 and/or the confidence interval at 95% for the intercept contains zero) were satisfied.

ACCURACY:
Acceptance criterion (% Recovery = 70%-110% and/or the confidence interval at 95% for the recovery contains 100%) proved to be satisfied.
Average recovery % = 95.76%
RSD% = 3.43%
95% confidence interval = 92.32% - 99.21%

PRECISION:
The acceptability criterion (RSD% experimental ≤ 20%) was respected.
RSD% = 2.91%

WATER SOLUBILITY:
The working solutions of the preliminary test were also analysed after 96 hours at controlled room temperature, using the validated method. The results are reported in Table 1.

Table 1: Analysis of the working solutions

Working solution of preliminary test	Weight of the test substance in 100 mL of water HP (g)	Concentration (µg/mL) of test product
1	0.0984	0.1943
2	0.1128	0.3751
3	0.1130	0.3605

Conclusions:

The preliminary test of the water solubility of Formononetin was performed according to OECD 105 by a HPLC-UV method. The analytical method used for the analyte quantification was successfully validated: the HPLC-UV proved to be specific, linear, precise and accurate. Since the water solubility value after the preliminary test proved to be less than 0.02 g/L, the flask method was not performed.

The water solubility of Formononetin can therefore be predicted to be less than 20 mg/L.

Description of key information

The preliminary test of the water solubility of Formononetin was performed according to OECD 105 by a HPLC-UV method. The analytical method used for the analyte quantification was successfully validated: the HPLC-UV proved to be specific, linear, precise and accurate. Since the water solubility value after the preliminary test proved to be less than 0.02 g/L, the flask method was not performed.

The water solubility of Formononetin can therefore be predicted to be less than 20 mg/L.