Registration Dossier

Physical & Chemical properties

Density

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Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 October 1996 and 9 January 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study followed guideline from OECD andEC and in accordance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Principles of method if other than guideline:
PERFORMANCE OF THE TEST
Test temperature: 20°C ± 0.5°C.
A clean, dry pycnometer was accurately weighed and then filled to the limits of its capacity with distilled water. The pycnometer was left to stand for 1 hour in a water bath at 20°C. It was then carefully stoppered without trapping air, dried and re-weighed. The procedure was repeated with the same pycnometer using hexane.
To the clean, dry and accurately weighed pycnometer test substance (ca 15 g) was added. The pycnometer was re-weighed and then the test substance covered with hexane. After vigorously shaking of the stoppered pycnometer to suspend the test substance, any bubbles were removed by ultrasonifying for 5 minutes. The pycnometer was then completely filled with hexane, equilibrated and weighed as before.
Two tests were performed concurrently using separate pycnometers
GLP compliance:
yes
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Date received:2 October 1996
Chemical class: 2-Ethoxy-5- (4methyl- l-piperazinesulphonyl) benzoic acid.
Pharmaceutical intermediate
White powder. Room temperature.

Results and discussion

Density
Type:
relative density
Density:
1.39

Any other information on results incl. tables

WEIGHINGS                    Test1                           Test2

(g)                              (g)

 

 

Pycnometer

33.8170

33.6800

Pycnometer+water

81.1546

83.8909

Massofwater

47.3376

50.2109

 

Pycnometer

 

33.8172

 

33.6800

Pycnometer+hexane

65.9406

67.7258

Massofhexane

32.1234

34.0458

 

Pycnometer

 

33.8162

 

33.6795

Pycnometer+testsubstance

49.7812

49.1568

Pycnometer+testsubstance+hexane

74.0930

75.6476

Massoftestsubstance

15.9650

15.4773

Massofhexane

24.3118

26.4908

Applicant's summary and conclusion

Conclusions:
The relative density (D o) ofUK-143,108 is 1.39