Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented determiantion of the particle size distribution following in general ISO 13320 and USP <429>.
Qualifier:
equivalent or similar to
Guideline:
other: ISO 13320
Qualifier:
equivalent or similar to
Guideline:
other: USP <429>
Principles of method if other than guideline:
The particle size distribution is measured by laser diffraction. The method depends on the analysis of the diffraction pattern produced when particles are exposed to a collimated beam of light. As the patterns are characteristic of the particle size, mathematical analysis can produce an accurate,
repeatable picture of the size distribution. The analysis assumes spherical particles and is based on an optical model, e.g. the Fraunhofer approximation.
The method is described in general in ISO 13320 and USP <429>.
The powder is fed into an air stream by a delivery system (DPS Tornado), which automatically adjusts for optimum obscuration in the measurement cell. The air stream is generated by vacuum to ensure the dispersion of cohesive powders without milling fragile materials. Although the particle size distribution is determined in an air stream, the measured particle sizes do not represent "aerodynamic" diameters, but rather "geometric" diameters.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
1.6 µm
St. dev.:
0.2
Remarks on result:
other: SD calculated from the means of three different runs date reported.
Percentile:
D10
Mean:
0.6 µm
St. dev.:
0.1
Remarks on result:
other: SD calculated from the means of three different runs date reported.
Percentile:
D90
Mean:
6.2 µm
St. dev.:
0.9
Remarks on result:
other: SD calculated from the means of three different runs date reported.
No.:
#1
Size:
0.577 µm
Distribution:
10 %
No.:
#1
Size:
1.376 µm
Distribution:
50 %
No.:
#1
Size:
5.339 µm
Distribution:
90 %
No.:
#2
Size:
0.585 µm
Distribution:
10 %
No.:
#2
Size:
1.568 µm
Distribution:
50 %
No.:
#2
Size:
6.209 µm
Distribution:
90 %
No.:
#3
Size:
0.597 µm
Distribution:
10 %
No.:
#3
Size:
1.781 µm
Distribution:
50 %
No.:
#3
Size:
7.118 µm
Distribution:
90 %

The volume distribution (average ) is 0.6 µm (d10), 1.6 µm (d50), and 6.2 µm (d90), all rounded to one digit.

Conclusions:
The volume distribution (average ) is 0.6 µm (d10), 1.6 µm (d50), and 6.2 µm (d90).
Executive summary:

The particle size distribution of tin disulfide was measured by laser diffraction in an air stream. The volume distribution (average) is 0.6 µm (d10), 1.6 µm (d50), and 6.2 µm (d90). The result is considered relevant for the risk assessment.

Description of key information

The volume distribution (average ) is 0.59 µm (d10), 1.58 µm (d50), and 6.22 µm (d90).

Additional information

The particle size distribution of tin disulfide was measured by laser diffraction in an air stream. The volume distribution (average) is 0.59 µm (d10), 1.58 µm (d50), and 6.22 µm (d90). The result is is considered relevant for the risk assessment.