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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:
May 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: European Pharmacopeia
Principles of method if other than guideline:
The diffraction of a lazer beam by the particules was analysed by the apparatus. The intensity and the picture of the diffraction are a fonction of the size of the particules. The computer treatment of the pictures gives the granulometric distributions.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Mass median aerodynamic diameter:
244 µm
Geometric standard deviation:
8
No.:
#1
Size:
32 µm
Distribution:
4 %
No.:
#2
Size:
63 µm
Distribution:
5 %
Remarks on result:
other: Cumulative fraction : 9%
No.:
#3
Size:
80 µm
Distribution:
4 %
Remarks on result:
other: Cumulative fraction: 13%
No.:
#4
Size:
100 µm
Distribution:
5 %
Remarks on result:
other: Cumulative fraction: 18%
No.:
#5
Size:
160 µm
Distribution:
16 %
Remarks on result:
other: Cumulative fraction: 34%
No.:
#6
Size:
200 µm
Distribution:
10 %
Remarks on result:
other: Cumulative fraction: 44%
No.:
#6
Size:
250 µm
Distribution:
13 %
Remarks on result:
other: Cumulative fraction: 57%
No.:
#7
Size:
315 µm
Distribution:
14 %
Remarks on result:
other: Cumulative fraction: 71%
No.:
#8
Size:
500 µm
Distribution:
23 %
Remarks on result:
other: Cumulative fraction: 94%
No.:
#9
Size:
800 µm
Distribution:
5.8 %
Remarks on result:
other: Cumulative fraction: 99.8%
No.:
#10
Size:
> 800 µm
Distribution:
0.2 %
Conclusions:
The particle size distribution of Maltitol was determined according to the European Pharmacopeia with a Laser Diffraction Granulometer (dry phase). The mean particle diameter was calculated to be 244 µm ± 8 µm .
Executive summary:

The particle size distribution of Maltitol was determined according to the European Pharmacopeia. The particule size was determined with a lazer diffraction granulometer in dry phase.

The lazer beam is diffracted by the particules and the intensity and the picture of the diffraction are a fonction of the size of the particules. The granulometric distribution is provided for the following mean diameters : 32, 63, 80, 100, 160, 200, 250, 315, 500, and 800 µm and it gives the following values 4, 5, 4, 5, 16, 10, 13, 14, 23, 5.8 and 0.2 % respectively.

The mean particle diameter was calculated to be 244 µm ± 8 µm.

Description of key information

The particle size distribution of Maltitol was determined according to the European Pharmacopeia with a Laser Diffraction Granulometer (dry phase). The mean particle diameter was calculated to be 244 µm ± 8 µm .

Additional information

The particle size distribution of Maltitol was determined according to the European Pharmacopeia. The particule size was determined with a lazer diffraction granulometer in dry phase.

The lazer beam is diffracted by the particules and the intensity and the picture of the diffraction are a fonction of the size of the particules. The granulometric distribution is provided for the following mean diameters : 32, 63, 80, 100, 160, 200, 250, 315, 500, and 800 µm and it gives the following values 4, 5, 4, 5, 16, 10, 13, 14, 23, 5.8 and 0.2 % respectively.