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Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10-14 March 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern guideline conform study performed in GLP certified laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch No. RW 2013-10-22
Expiry date 22 October 2018
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- > 9.28 - < 17.2 g/L
- Temp.:
- 20 °C
- pH:
- > 5.69 - < 5.8
- Details on results:
- The water solubility of Yellow LF 6881 was determined to be 13.24 3.96 g/L (95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.
Any other information on results incl. tables
The calibration solutions were prepared on each analytical occasion.Thecalibration sampleswere analysed by HPLC with three parallel injections from each.
The test item concentrations were calculated with the help of the calibration equations given in Table 1.
One exemplary calibration curve is given in Figure 1.
Representative chromatograms can be seen in the Appendix 3.
Table 1. Regression data
Analytical occasion | Constant | X Coefficient | R. Squared |
12 March 2014 | 4061 | 76041 | 1.000 |
13 March 2014 | 976 | 75958 | 1.000 |
14 March 2014 | 734 | 78645 | 1.000 |
Measured concentrations of Yellow LF 6881 are summarised in Table 2. The repeatability of the determination was < 15 % and thus within the range required by the guidelines.
Table 2. Results of the determination of water solubility of Yellow LF 6881
Sampling time | Measured concentrationoftest item,g/L | Measured pH | |
Test vessels | Mean | ||
After 24h | 15.44 | 13.35 | 5.76 |
12.41 | 5.70 | ||
12.22 | 5.77 | ||
After 48h | 15.18 | 14.77 | 5.72 |
14.19 | 5.75 | ||
14.96 | 5.69 | ||
After 72h | 10.90 | 11.59 | 5.76 |
12.08 | 5.80 | ||
11.80 | 5.81 | ||
Mean with confidence interval (95 %) | 13.24 ± 3.96 | 5.75 | |
RSD % | 12 | - | |
Applicant's summary and conclusion
- Conclusions:
- In conclusion the water solubility of Yellow LF 6881 was determined to be 13.24 +/- 3.96 g/L (95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.
- Executive summary:
The water solubility of Yellow LF 6881 was determined to be13.24 ± 3.96 g/L(95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test.
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