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Melting point / freezing point

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Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Method not specified
GLP compliance:
no
Melting / freezing pt.:
54 °C
Atm. press.:
ca. 1 013 hPa

Pressure was not reported. It is assumed that melting point was tested at ambient conditions.

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed literature
Principles of method if other than guideline:
Method not specified
GLP compliance:
no
Melting / freezing pt.:
>= 52 - <= 56 °C
Atm. press.:
ca. 1 013 hPa

Pressure was not reported. It is assumed that melting point was tested at ambient conditions.

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Method not specified
GLP compliance:
no
Melting / freezing pt.:
54 °C
Atm. press.:
ca. 1 013 hPa

Pressure was not reported. It is assumed that melting point was tested at ambient conditions.

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Certificate of Analysis
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: European Pharmacopoeia 2.2.15. Melting Point - Open Capillary Method
GLP compliance:
no
Type of method:
other: Open Capillary Method
Key result
Melting / freezing pt.:
ca. 54.3 °C
Atm. press.:
ca. 1 013 hPa

Lower measured melting point: 46.0 °C

Higher measured melting point: 58.0 °C

The pressure was not reported in the certificate of analysis; melting point measured according to open capillary method, therefore ambient conditions can be assumed (pressure ca. 1013 hPa).

Description of key information

Melting point = 54.3 °C (Eur. Ph. 2.2.15, Open Capillary Method)

Pressure not reported, assumed to be normal pressure (1013 hPa).

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
54.3 °C

Additional information

Melting point values from three reliable sources have been chosen as supporting information:

54 °C (Handbook of Chemistry and Physics – 86th Edition 2005-2006, 2005)

54 °C (The Merck Index - An Encyclopedia of Chemicals and drugs - Ninth Edition, 1976)

52-56 °C (Souto et al., J Microencapsul, 2005)