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Water solubility

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water solubility
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Physical Appearance (with color): Off-white crystal
Storage Condition: Ambient (21 to 29°C)
Key result
Water solubility:
4.84 mg/L
Conc. based on:
test mat.
20 °C
Details on results:
- System suitability: System suitability meets the acceptance criterion as the % RSD obtained was 0.12% to 1.15% which is less than 2.0% and theoretical plates obtained was 6626 to 10415 which is more than 2000 and asymmetry obtained was 1.03 to 1.19 which is less than 2.0.
- Specificity: Specificity meets the acceptance criterion for the test item as the interference obtained for diluent was 1.57% and diluent fortified with water was 4.30% which is < 30 % of the standard response at LOQ.
- Limit of Detection (LOD) and Limit of Quantification (LOQ): The LOD was determined at 0.10 mg/L concentration based on S/N ≈ 2/1 and LOQ was determined at 0.49 mg/L concentration based on S/N ≥ 10/1 for the test item.
- Linearity: Linearity meets the acceptance criterion for Phantolid Crystals as the correlation coefficient obtained was 0.9992 to 1.0000 which is ≥ 0.99.
- Accuracy (% Recovery) and Precision (% RSD): Recovery for Phantolid Crystals meets the acceptance criterion as the % recovery obtained was 94.42% for LOQ and 101.52% for 10 LOQ which is within the range 70 % to 110 % of the nominal concentration for each fortification level. Precision meets the acceptance criterion as the % RSD for Phantolid Crystals obtained was 0.93% for LOQ and 0.53% for 10 LOQ which is ≤ 20.0%.

Description of key information

The water solubility of the test substance is 4.84 mg/L (OECD 105 and GLP).

Key value for chemical safety assessment

Water solubility:
4.84 mg/L
at the temperature of:
20 °C

Additional information