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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:
Jan 2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
counted distribution
Specific details on test material used for the study:
Test substance: L-Carnitine (CIS 1000)
Batch: Lot-No: A10018 (Carnipure crystalline)
Mass median aerodynamic diameter:
317.54 µm
Remarks on result:
not measured/tested
Percentile:
D10
Mean:
91.83 µm
St. dev.:
0
Remarks on result:
other: St. dev. not available
Percentile:
D50
Mean:
266.35 µm
St. dev.:
0
Remarks on result:
other: St. dev. not available
Percentile:
D90
Mean:
623.96 µm
St. dev.:
0
Remarks on result:
other: St. dev. not available
Conclusions:
Results of the Particle Size Distribution measurements:
d(0.1): 91.83 μm d(0.5): 266.35 μm d(0.9): 623.96 μm
Volume weighted mean: 317.54 μm
Executive summary:

For the measurement, a dispersion of L-Carnitine (CIS 1000) Lot-No: A10018 in Isooctane/2-Propanol (7:3)

as a start medium and at least Isooctane/2-Propanol (9:1) as a measurement medium was used to ensure

that the sample material will not dissolved additional in the solvent.

Results of the Particle Size Distribution measurements:

d(0.1): 91.83 μm d(0.5): 266.35 μm d(0.9): 623.96 μm

Volume weighted mean: 317.54 μm

Description of key information

For the measurement, a dispersion of L-Carnitine (CIS 1000) Lot-No: A10018 in Isooctane/2-Propanol (7:3)

as a start medium and at least Isooctane/2-Propanol (9:1) as a measurement medium was used to ensure

that the sample material will not dissolved additional in the solvent.

Results of the Particle Size Distribution measurements:

d(0.1): 91.83 μm d(0.5): 266.35 μm d(0.9): 623.96 μm

Volume weighted mean: 317.54 μm

Additional information