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Water solubility

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water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 May - 16 June 2018
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 105 (Water Solubility)
GLP compliance:
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
20 °C
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

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

Additional information