Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Given the precision required (the solubility is determined as a range), no sufficient human error is expected which could lead to a non reliable result.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Pharmacopoeia 5.0 : Solubility
Principles of method if other than guideline:
1-Tared a dried volumetric flask at a fixed temperature of 20°C.
2-Fill in the flask with 100mg of the substance
3-Add 0.1ml of water and check if the sustance is solubilized (very soluble): if not go to step 4)
4-Add 0.9mL of water and check if the sustance is solubilized (easily soluble): if not go to step 5)
5-Add 2mL of water and check if the sustance is solubilized (soluble): if not go to step 6)
6-Add 7mL of water and check if the sustance is solubilized (moderately soluble): if not go to step 7)
7-Tared a dried volumetric flask at a fixed temperature of 20°C.
Fill in the flask with 10mg of the substance, add 10mL of water and check if the sustance is solubilized (slightly soluble): if not go to step 8)
8-Tared a dried volumetric flask at a fixed temperature of 20°C.
Fill in the flask with 1mg of the substance, add 10mL of water and check if the sustance is solubilized (very poorly soluble).
GLP compliance:
yes
Type of method:
other: European Pharmacopoeia 5.0 : Solubility

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
>= 100 - <= 1 000 mg/L
Temp.:
20 °C
pH:
ca. 2.6
Details on results:
100mg of the substance is soluble in 10ml of water.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
Solubility at 20°C in water is 100 to 1000mg/L =>The substance is moderately soluble according to European Pharmacopoeia 5.0