Registration Dossier

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:
August 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method. The substance is considered to be adequately characterised

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: white powder
- Storage: in a dark place at room temperature
- Batch : 15 262
- Manufacturing date: September 14th, 2015
- Expiry date: September 14th, 2018
Specific details on test material used for the study:
- Particle size: non spherical
- Particle size refractive index: 1.538 (sugars)
- Particle size absorption index: 0.010 (sugars)
- Approximate density of the powder: 1 g/cm3

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D50
Mean:
ca. 164 µm
Remarks on result:
other: RSD = 1.36%
Key result
Percentile:
D10
Mean:
ca. 72.9 µm
Remarks on result:
other: RSD = 1.60%
Key result
Percentile:
D90
Mean:
ca. 318 µm
Remarks on result:
other: RSD = 2.39%

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the test substance was determined by laser diffraction according to ISO 13320-2009.
The test item has a median particle size D50 = 164.0 μm.
Executive summary:

The particle size distribution of the test substance was determined by laser diffraction according to ISO13320-2009 in an appropriate dispersive solvent.

The MIE diffusion model was used to obtain the volumetric distribution of the test substance.

9 measurements were made during the passage of the powder in the apparatus, the following parameters were determined:

D10= 72.9 µm (RSD = 1.60%)

D50= 164.0 µm (RSD = 1.36%)

D90= 318 µm (RSD = 2.39%)

All the RSD were below the limits definied by the ISO 13320, these measurements are considered to comply with the International Standard.