Registration Dossier
Registration Dossier
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EC number: 616-391-1 | CAS number: 76812-02-7
Melting point / freezing point
Administrative data
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiation: 24-09-1997 / Starting date: 24-11-1997 / End of laboratory investigations: 24-11-1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- thermal analysis
- Remarks:
- DSC (Differential Scanning Calorimetry)
Test material
- Reference substance name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 616-391-1
- Cas Number:
- 76812-02-7
- Molecular formula:
- C34 H41 N O4
- IUPAC Name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- Reference substance name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- IUPAC Name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- Details on test material:
- - Name of test material (as cited in study report): Fexofenadone-Ethylester
- Analytical purity: 98.65 % (w/w)
- Code-No.: HOE CG 0529 OY ZD99 0001
- Lot/batch No.: TAM 40-96-13 dated 27.08.1996
- Storage condition of test material: 2 Years in a refrigerator Exclusion of moisture. (information by the producer)
- Certificate No., date: dated 19.08.1997
- Expiration date of the certificate: August 1998
Constituent 1
Constituent 2
Results and discussion
Melting / freezing point
- Melting / freezing pt.:
- 121.7 °C
Applicant's summary and conclusion
- Conclusions:
- The melting of of the substance is 121.7 °C.
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