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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:
19 - 20 June 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission Joint Research Center "Particle Size Distribution, Fibre length and diameter Distribution" Guidance document, ECBT/TM/February 1996
Deviations:
no
Remarks:
There were no amendments to the study plan.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
- Batch n°: 00403487
- Analytical purity: > 98%
- Expiration date: 31 December 2003
- Storage condition: at room temperature
Percentile:
other: D5
Mean:
1.8 µm
St. dev.:
0.859
Percentile:
D10
Mean:
5.9 µm
St. dev.:
0.861
Key result
Percentile:
D50
Mean:
15.8 µm
St. dev.:
0.587
Percentile:
D90
Mean:
29.2 µm
St. dev.:
1.935
No.:
#1
Size:
1 µm
Distribution:
3.62 %
No.:
#2
Size:
5 µm
Distribution:
8.57 %
No.:
#3
Size:
10 µm
Distribution:
22.68 %

The results obtained during the measurements showed no relevant difference. The MMD mean value of 15.8 um with a standard deviation of +- 0.587 um as reported above. The standard deviation is smaller than 5 %, therefore the study is considered to be valid. In conclusion, using the laser diffraction method to study the particle size of substance T002615 is ranging between 0.3 um and 50 um.

Conclusions:
The mean mass diameter of the substance T002615 was determined with the laser diffraction method to be 15.8 µm.

Description of key information

The particle size distribution of T002615 was determined by the laser diffraction method in a Klimisch 1 GLP study (Tognucci, 2003).

The mean mass diameter was determined to be 15.8 µm.

Additional information