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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:
August 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Meets generally accepted scientific standards with acceptable restrictions, well documented and acceptable for assessment. Creatine is manufactured by drying of creatine monohydrate. The only difference between creatine and creatine monohydrate is the water content of the substances. Creatine (C4H9N3O2) does not contain water molecules, whereas creatine monohydrate contains one water molecule per substance molecule (C4H9N3O2 x H2O). This is not expected to lead to differences in the granolumetry of creatine compared to creatine monohydrate.
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Principles of method if other than guideline:
Laser diffraction method - The test was conducted according to the guidance of the apparatus used. A short description is given below:
The dry test substance is dispersed and passes a laser in form of an aerosol. In dependence on the particle size the laser is diffracted. The resulting so called “Fraunhofer” diffraction spectrum is bundled using a converging lens in a multi-element photo detector. In dependence of the particle size distribution a radial symmetric intensity distribution is generated. The measured intensity is analysed by a computer and converted into a particle size distribution.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
114.02 µm
Remarks on result:
other: SD not determined
No.:
#1
Size:
26.22 µm
Distribution:
10 %
No.:
#2
Size:
114.02 µm
Distribution:
50 %
No.:
#3
Size:
267.58 µm
Distribution:
90 %
No.:
#4
Size:
730 µm
Distribution:
100 %
Conclusions:
The median value of particle size of Creatine Monohydrate is 114.02 µm.
Executive summary:

The granulometric properties of Creatine Monohydrate were analysed with the laser diffraction method according to guideline ISO 13320 -1. The particle size distribution was determined using the particle size analysator HELOS KF (H0119) from Sympatec with a Sympatec RODOS dry dispersing unit. The test material was dried via dispersing and run in form of an aerosol fluent through a laser beam. The median value of particle size is 114.02 µm.

Description of key information

The granulometric properties of Creatine Monohydrate were determined with a laser diffraction method according to

guideline ISO 13320-1. The median value of particle size is 114.02 µm. This information is used for read-across to creatine.

Additional information

The granulometric properties of Creatine Monohydrate were analysed with the laser diffraction method according to guideline ISO 13320 -1. The particle size distribution was determined using the particle size analysator HELOS KF (H0119) from Sympatec with a Sympatec RODOS dry dispersing unit. The median value of particle size is 114.02 µm.