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Diss Factsheets

Administrative data

Endpoint:
boiling 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 investigation: 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:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.2 (Boiling Temperature)
GLP compliance:
yes
Type of method:
differential scanning calorimetry

Test material

Constituent 1
Chemical structure
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
Constituent 2
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

Results and discussion

Boiling point
Atm. press.:
1 013.3 hPa
Decomposition:
yes
Remarks:
After melting of the test substance at about 120°C no endothermal effect was observed only an exothermic decomposition beginning at 160 °C.
Decomp. temp.:
160 °C

Any other information on results incl. tables

The determination of the boiling point/boiling range by DSC,Mettler-ToledoTA8000, was carried out in standard aluminium pan with a hole. The precision of the procedure is approx. ± 0.5K.

After melting of the test substance at about 120°C, no endothermal effect was observed only an exothermic decomposition beginning at 160°C.

Applicant's summary and conclusion

Conclusions:
The melting point of the substance is 120°C.
After melting, the test substance shows an exothermal decomposition beginning at 160°C in the differential scanning calorimetry, So it is concluded that the test substance has no boiling point at atmospheric pressure.