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:
31.08.2009 - 04.11.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research md Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R-Pantolactone
- Physical state: solid
- Analytical purity: 99.6%
- Storage condition of test material: RT

Results and discussion

Particle size
Percentile:
D50
Mean:
2 000 - 4 000 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

Mesh size

(µm)

 5000
Mean (%)  17.27
 4000  48.53
 2000  33.94
 1000  0.12
 500  0.05
 250  0.03
 125  0.07
 75  0.00
<75   0.00

Applicant's summary and conclusion

Conclusions:
The main agglomerate size was found in the range of 4000 µm to 2000 µm.
Executive summary:

In the present study the sieving test with different sizes of sieves was performed. It can be stated that the particles of R-Pantolactone form agglomerates. The measurement of the single particles was not possible. There were only few fractions with a size below 250 pm in the sieve test. The main agglomerate size was found in the range of 4000 µm to 2000 µm.