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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to PhEur General Notices, USP, JP principle

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: PhEur Gneral Notices
Deviations:
no
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amlodipin FIA
- Substance type: yellow powder
- Physical state: powder
- Analytical purity: 98.8%
- Purity test date: 27.7.2007
- Lot/batch No.: X00336307I
- Expiration date of the lot/batch: 27.7.2007
- Stability under test conditions: stable
- Storage condition of test material: At room temperature, protective from light

Results and discussion

Water solubility
Water solubility:
< 1 other: g/10.000 ml
Temp.:
24 °C
pH:
5.66
Remarks on result:
other: The substance is practically insoluble in water.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: < 1g/10.000 ml
The substance is practically insoluble in water.