Registration Dossier
Registration Dossier
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EC number: 941-661-3 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27th June 2019 to 28th June 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 ''Particle Size Analysis by Laser Diffraction'' Handbook K
- Version / remarks:
- 2007
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
Test material
- Reference substance name:
- 3-tert-butyl-1-(3,5-dicarboxyphenyl)-1H-pyrazol-5-aminium chloride
- EC Number:
- 941-661-3
- Molecular formula:
- C15H18ClN3O4
- IUPAC Name:
- 3-tert-butyl-1-(3,5-dicarboxyphenyl)-1H-pyrazol-5-aminium chloride
- Reference substance name:
- Unidentified impurity
- IUPAC Name:
- Unidentified impurity
Constituent 1
impurity 1
Results and discussion
- Mass median aerodynamic diameter:
- ca. 92.6 µm
- Geometric standard deviation:
- ca. 1.616
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- 80.7 µm
- St. dev.:
- 0.161
- Remarks on result:
- other: median
- Percentile:
- D10
- Mean:
- 43.4 µm
- St. dev.:
- 0.193
- Percentile:
- D90
- Mean:
- 135 µm
- St. dev.:
- 0.852
Particle size distribution at different passages
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 0.21 %
- Remarks on result:
- other: by volume of sample
Applicant's summary and conclusion
- Conclusions:
- MMAD 92.6 µm
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