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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
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 with acceptable restrictions
Remarks:
Well documented, scientifically sound study that used appropriate measurement instrumentation. Work performed following cGMP. Report was reviewed by laboratory Quality Assurance Department.
Qualifier:
according to
Guideline:
other: see principles of method if other than guideline.
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
Other quality assurance:
other: GMP
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
7.33 µm
St. dev.:
0
Key result
Percentile:
D50
Mean:
28.32 µm
St. dev.:
0
Key result
Percentile:
D90
Mean:
60.91 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 3.71 m^2/g.

Conclusions:
This tungsten trioxide registraion covers a highly pure (>99.0%) monoconstituent substance with a monoclinic form, traces of ammonia and carbon, and a particle size distribution on the microsized region.

Description of key information

Mean D10, D50, and D90 = 7.83, 28.32, and 60.91 µm, respectively.
The specific surface area of the test substance sample (as determined by B.E.T.) was found to be 3.71 m2/g.

Additional information