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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed study according to internal guide

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: company SOP
Qualifier:
equivalent or similar to guideline
Guideline:
other: ISO 13320 -1
Principles of method if other than guideline:
A laser beam is shone into a cloud of dispersed particles. The diffraction pattern is measured by a series of photodetectors at different angles. Large particles scatter the light mainly in the forward direction, small particles at larger angles. This is described by the Mie theory. With a suitable fit algorithm, the particle size distribution is adjusted so that calculated and observed scattering intensities agree. Particles within a size range of 1 to 1000 µm can be detected.
Laser diffraction particle sizing measured using Mastersizer 2000 (Malvern Instruments Ltd.). Within the Mastersizer 2000 system, consistent and controlled measurements are achieved through the clear specification of sample dispersion units and critical operating parameters, which ensures proper quality control according to ISO 13320 -1.
Standard operating procedure for dispersion of dry pigment is applied. Particle flow controlled using variable feed-rate vibrating tray unit (Scirocco) . Dispersion achieved by accelerating particles with a compressed air stream of 4 bar.
Measuring time: 10 s; 2 measurements within an interval of 5s are performed (averaged for result)
Concentration: 0.0006 %Vol
Dual wavelength measurement (He-Ne-Laser and blue solid state light source)
Evaluation using Fraunhofer approximation.
Given standard deviation is based on the general experience with the method and pigments. The estimated values are typical standard deviations for pigments:
D10: 4% of D10 (minimum value 0,05 µm)
D50: 13% of D50 (minimum value 0,1 µm)
D90: 29% of D90 - D50
GLP compliance:
no
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride
EC Number:
618-990-3
Cas Number:
939961-06-5
Molecular formula:
C15H15N3O3xClH
IUPAC Name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride
Details on test material:
Purity: 94.7 % (w/w)

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
11.3 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
1.1 µm
St. dev.:
0.1
Percentile:
D50
Mean:
11.3 µm
St. dev.:
1.5
Percentile:
D90
Mean:
238.2 µm
St. dev.:
65.8

Applicant's summary and conclusion

Conclusions:
The mass median diameter D50 of the substance is 11.3 µm.
Executive summary:

The particle size distribution was determined with the apparatus Malvern Mastersizer 2000, unit: Scirocco 2000. The mass median diameter D50 was found to be 11.3 µm.