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Melting point / freezing point

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

GLP compliance:

no

Other quality assurance:

other: ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

Remarks:

also A2LA

Type of method:

differential scanning calorimetry

Key result

Melting / freezing pt.:

79.6 °C

Atm. press.:

101.3 kPa

Decomposition:

no

Key result

Melting / freezing pt.:

107.5 °C

Atm. press.:

101.3 kPa

Decomposition:

no

Key result

Melting / freezing pt.:

128.4 °C

Atm. press.:

101.3 kPa

Decomposition:

no

Conclusions:

Pentamid KH displayed no freezing point evident for the sample on cooling. A possible glass transition was evident on heating. The average onset of the transition was at 37.3°C. Three average melting points were found at 79.6°C, 107.5°C, and 128.5°C.

Reference 2

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2014 August - 2017 May

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Experimental methods using nationally accepted methods.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Principles of method if other than guideline:

Melting: Capillary method with liquid bath or block.- Principle of test: Capillary method
- Short description of test conditions: Sample was loaded into a capillary tube and heated to a plateau temperature ~10 degrees below the expected melting point in a Stuart SMP20 melting point apparatus. Temperature was increased by a constant rate until the sample began to melt. Record the range at which the sample melted. Benzoic acid was used as a standard.
- Parameters analysed / observed: Temperature, physical state of substance.

GLP compliance:

no

Type of method:

capillary method

Key result

Melting / freezing pt.:

>= 120 - <= 133 °C

Atm. press.:

101.3 kPa

Decomposition:

no

Remarks on result:

other: no data on decomposition

Remarks:

not noted to decompose

Date	Batch Number	Melting Point (°C)
19/08/2014	43040	124
12/05/2015	44673	128
04/08/2015	45219	128.4
09/05/2016	46679	129.1
09/05/2016	46680	126.3
09/05/2016	46681	133
14/11/2017	47652	120
18/05/2017	48654	126.1
18/05/2017	48655	129.6
18/05/2017	48656	130
18/05/2017	48657	130

     

Conclusions:

Various samples of the commercial test substance was observed to melt over the range of 120 to 133 °C at approximately 101.3 kPa.

Description of key information

No melting/freezing point observed in a DSC study

Additional information

There was no freezing point evident for the sample on cooling. A possible glass transition was evident on heating.