(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic 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:

31 May - 16 June 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes

Type of method:

flask method

Specific details on test material used for the study:

- Test material: Balsalazide acid
- Batch number: 0400
- Expiry date: April 2019
- Purity: >98%
- Storage: Room temperature
- Stability: 12 months

Since the test material was a mixture of powder and pieces of various sizes, it was necessary to grind and pulversie the material.

Key result

Water solubility:

1.62 g/L

Conc. based on:

test mat.

Incubation duration:

<= 4 d

Temp.:

20 °C

pH:

5.02

Details on results:

The analytical method proved to be specific, linear, precise and accurate, as follows:

Specificity: It was demonstrated that the blank (mobile phase) did not produce any peak interfering with those of the active ingredient.
Linearity: R: 0.9999; R2: 0.9999; Slope: 40166.731; Intercept: 3.409; Confidence interval at 95% for the intercept: [-0.0008;0.0008]
Accuracy: Average recovery: 99.15 [95% confidence limits 98.55, 99.76]; RSD: 0.86%
Precision: Assay: 0.133% w/w; RSD%: 1.69

Conclusions:

The water solubility of Balsalazide acid at 20°C was 1.62 g/L.

Description of key information

The water solubility of Balsalazide acid at 20°C was determined according to OECD Guideline 105 and was found to be 1.62 g/L.

Key value for chemical safety assessment

Water solubility:

1.62 g/L

at the temperature of:

20 °C