Registration Dossier
Registration Dossier
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EC number: 617-116-8 | CAS number: 80573-04-2
Water solubility
Administrative data
Link to relevant study record(s)
- 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.
Reference
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
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