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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Physical & Chemical properties

Melting point / freezing point

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January-March 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test performed following pharmacopea method
Qualifier:
according to guideline
Guideline:
other: USP method<651>
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Principles of method if other than guideline:
The product is introduced in a tube, containing a mercury thermometer on a height of 5 to 5.7 cm. Put the tube in a cold bath (mixture of ice, salt and acetone), having a temperature of about -12°C. The product temperature is recorded every 30 seconds until the product is frozen or until the bath temperature is reached (approximately -10°C).
GLP compliance:
no
Type of method:
other: The temperature at which a substance passes from the liquid to the solid state upon cooling is a useful index to purity if heat is liberated when the solidification takes place, provided that any impurities present dissolve in liquid and not in solid
Melting / freezing pt.:
< -10 °C
Atm. press.:
1 atm
Decomposition:
no
Remarks on result:
other: The batch temperature could not reach - 20°C because of the solvant mixture used: ice, salt and acetone
Conclusions:
Freezing temperature of the test item is less than -10°C.
Executive summary:

Freezing temperature of the test item is less than -10°C.

Description of key information

Freezing temperature of test item is less than -10°C.

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
-10 °C

Additional information

In study conducted according pharmacopea method USP<651>,The test item temperature is recorded until the bath temperature is reached (approximately -10°C).Lower temperature could not be reached due to the solvant mixture used.