Registration Dossier
Registration Dossier
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EC number: 609-076-5 | CAS number: 35139-67-4
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017/05/11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- 2,4-Diamino-6-chloropyrimidine-3-oxide
- EC Number:
- 609-076-5
- Cas Number:
- 35139-67-4
- Molecular formula:
- C4H5ClN4O
- IUPAC Name:
- 2,4-Diamino-6-chloropyrimidine-3-oxide
- Test material form:
- solid
- Remarks:
- white/beige solid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: > 99%- Lot/batch No.: 0160405- Expiration date of the lot/batch: 21/02/2018
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- ca. 1.3 µm
- St. dev.:
- 0
- Key result
- Percentile:
- D50
- Mean:
- ca. 7.1 µm
- St. dev.:
- 0
- Percentile:
- D90
- Mean:
- ca. 44.5 µm
- St. dev.:
- 0.45
Any other information on results incl. tables
Particle Size Distribution
Two test series of 3 measurements each were performed with the fine fraction <2000 µm of the test item.
Test series 1:
D10: 1.3 µm
D50: 7.1 µm (Median diameter)
D90: 44.1 µm
Test series 2:
D10: 1.3 µm
D50: 7.1 µm (Median diameter)
D90: 45.0 µm
Average
D10: 1.3 µm
D50: 7.1 µm (Median diameter)
D90: 44.5 µm
The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement.
Applicant's summary and conclusion
- Conclusions:
- The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement.
- Executive summary:
The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement, according to ISO13320 (2009).
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