Registration Dossier
Registration Dossier
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EC number: 208-874-7 | CAS number: 544-62-7
Melting point / freezing point
Administrative data
- 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:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- 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:
- no
- Type of method:
- capillary method
Test material
- Reference substance name:
- Batilol
- EC Number:
- 208-874-7
- EC Name:
- Batilol
- Cas Number:
- 544-62-7
- Molecular formula:
- C21H44O3
- IUPAC Name:
- 3-(octadecyloxy)propane-1,2-diol
- Test material form:
- solid: particulate/powder
Constituent 1
- 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.
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