Registration Dossier

Administrative data

melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guideline
according to
other: JSQI (The Japanese Standards of Quasi-drug Ingredients), Melting Point Measurement Method 2
Principles of method if other than guideline:
Melt carefully the sample at temperature as low as possible, and, taking care to prevent bubbling, draw it into a capillary tube about 120 mm long, which is left open at both ends, to a depth of about 10 mm.
Allow the charged tube to stand for 24 hours at a temperature not exceeding 10°C, or for not less than 2 hours in contact with ice, holding the tube not to allow the elution of the sample from it.
Then attach the tube to the thermometer (No.1) by means of a rubber band so that the sample is on a level with the middle part of the mercury bulb. Adjust the tube in a water-containing beaker to such a position that the upper edge of the sample is 10 mmm below the water level.
Heat the beaker with constant stirring until a temperature 5°C below the expected melting point is attained. Then regulate the rate to 1°C per minute. The temperature at which the sample is observed to rise in the capillary tube is taken as the melting point.
GLP compliance:
Type of method:
capillary method

Test material

Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Description: White to pale yellow powder
Batch: 7398
Purity : 99,4%
Test substance storage: room temperature
Stability under storage conditions: 12 months from manufacturing date
Expiry date: 2018/03/27

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
ca. 67.2 °C
Atm. press.:
ca. 1 atm

Applicant's summary and conclusion

Executive summary:

The melting point test was performed according to the JSQI (The Japanese Standards of Quasi-drug Ingredients), Melting Point Measurement Method 2.

The melting point of the test item was 67.2°C.