Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
stability: thermal, sunlight, metals, other
Remarks:
Migrated from section 'Stability: thermal, sunlight, metals'
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Principles of method if other than guideline:
DSC

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amlodipin-ETA
- Substance type: organic compound
- Isomers composition: No chiral centre in the molecule
- Physical state: very viscose red to brown coloured oil
- Analytical purity: 85%
- Storage condition of test material: room temperature
- Impurities (identity and concentrations): 2-triphenylmethylamino ethanole, 7,71 HPLC area percent,
- Purity test date: 04. 2008
- Lot/batch No.: 30007398
- Expiration date of the lot/batch: 10. 2008

Results and discussion

For thermal stability study

Test substance thermally stable:
no
Transformation products:
yes

Applicant's summary and conclusion