Registration Dossier
Registration Dossier
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EC number: 208-768-0 | CAS number: 541-15-1
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- 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
Reference
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
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