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Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
N/A to 2009-05-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that used appropriate measurement instrumentation. Work performed following cGMP guidelines. Report was reviewed by laboratory Quality Assurance Department.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
The particle size was analyzed by the Malvern MasterSizer LASER diffracter. This instrument is an ensemble analyzer that calculates a volume distribution from the LASER diffraction pattern of a cloud of particles. This raw scatter data is then processed using a complex algorithm and presented on the basis of an equivalent spherical diameter. This instrumentation is approved by ECHA Guidance, 2008 (Chapter R.7a, pg. 148)
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
15.94 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Key result
Percentile:
D10
Mean:
3.78 µm
St. dev.:
0
Key result
Percentile:
D50
Mean:
15.94 µm
St. dev.:
0
Key result
Percentile:
D90
Mean:
47.66 µm
St. dev.:
0

No specific standard deviation were identified for the particle distribution data although significant robust data was presented in the laboratory report.

The B.E.T. Surface Area of the test substance sample was determined to be 11.12 m2/g.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Well documented study with particle size and surface area examination conducted with sound scientific methodology. However, purpose of study went beyond examination of physical characteristics and few details were provided regarding these determinations.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Particle morphology and size were determined by scanning electron microscopy (SEM). Specific surface are (SSA) was determined by nitrogen gas adsorption.
GLP compliance:
not specified
Type of method:
microscopic examination
Type of distribution:
counted distribution
Mass median aerodynamic diameter:
> 3.1 - < 4.9 µm
Geometric standard deviation:
> 1.5 - < 1.9
Key result
Percentile:
D50
Mean:
> 2.1 - < 3.1 other: um (GM aerodynamic fiber diameter for WO2.81, WO2.66 and WO2.51)
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Key result
Percentile:
other: GM length for WO2.81
Mean:
4 µm
St. dev.:
1.9
Key result
Percentile:
other: GM length for WO2.66
Mean:
4.9 µm
St. dev.:
1.5
Key result
Percentile:
other: GM length for WO2.51
Mean:
3.1 µm
St. dev.:
1.7

In addition to the table above, the following results were obtained:

Study Material  Aspect Ratio (GSD) um  GM width (GSD)  Specific surface area m2/g
 WO2.81  8.3 (1.8)  0.5 (1.5)   2.85 +/- 0.02
 WO2.66  7.9 (1.7)  0.6 (1.4)   1.50 +/- 0.07
 WO2.51  6.9 (1.8)  0.5 (1.4)   2.10 +/- 0.02
 WO3  NA (non-fibrous)   NA (non-fibrous)  0.75 +/- 0.03
 WO2.98   NA (non-fibrous)   NA (non-fibrous)   11.10 +/- 0.76

Description of key information

One TBO sample was found to have: D10, D50, and D90 = 3.78, 15.94, and 47.66 µm, respectively. The specific surface area of the test substance sample (as determined by B.E.T.) was found to be 11.12 m2/g. The GM aerodynamic fiber diameter for WO2.81, WO2.66 and WO2.51 were found to be >2.1 and <3.1µm for a different sample of TBO.

Additional information