Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 January 2016 to 17 February 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
(EC 440/2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
pycnometer method

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide
EC Number:
812-038-2
Cas Number:
1192651-80-1
Molecular formula:
C23 H46 N4 O6 S
IUPAC Name:
N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): SAM-3
- Lot/batch No.: SAM-3/660-137/K1
- Material number: P60689-51
- Storage conditions: ambient temperature, dry, well ventilated area protected from sunlight.

Results and discussion

Density
Key result
Type:
relative density
Density:
1.12 g/cm³
Temp.:
20 °C
Remarks on result:
other: D20/4

Any other information on results incl. tables

Determination of the density of the immersion liquid (IL)

Mass of Empty Pycnometer (g): 23.91

Mass water & Pycnometer (g): 48.90

Mass of IL & Pycnometer (g): 48.07

Mass IL required to fill empty pycnometer (g): 24.16

Volume of Pycnometer (ml): 25.1

Density of water= mass of water/volume of pycnometer= 0.997 g/cm3

Density of the immersion liquid=(mass of IL/mass of water)*density of water= 0.963 g/cm3 (963 kg/m3)

Determination of the density of the test substance

Mass of Empty Pycnometer (g): 23.91 / 23.91 (exp. 1/ exp. 2)

Mass of Sample and Pycnometer (g): 34.63 / 34.97 (exp. 1/ exp. 2)

Mass of Sample (g): 10.72 / 11.05 (exp. 1/ exp. 2)

Mass of Sample, Pycnometer and Immersion liquid (IL): 49.66 / 49.53 (exp. 1/ exp. 2)

Mass of IL added to fill the pycnometer containing the sample (g): 15.03 / 14.56 (exp. 1/ exp. 2)

Density of substance= [mass of sample *density of IL (i.e. 0.963)] / [mass of IL required to fill the empty pycnometer (i.e. 24.16 g) - mass of IL added to fill the pycnometer containing the sample]

Calculated density : 1.131 / 1.110 g/cm3 (exp. 1/exp.2)

Applicant's summary and conclusion

Conclusions:
Using a volume pycnometer, the relative density of the substance at 20°C has been determined as 1.12. The study was in accordance with EC A.3 and in compliance with GLP.