Registration Dossier
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EC number: 813-399-9 | CAS number: 1821694-26-1
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable
- Qualifier:
- according to guideline
- Guideline:
- other: United States Pharmacopoeia
- Deviations:
- no
- Principles of method if other than guideline:
- Determination of the particle size distribution with sieves (USP method) is described below.
- GLP compliance:
- no
- Type of method:
- sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4147N0724
- Purity test date: 2015-08-04 - No.:
- #1
- Size:
- > 800 µm
- Distribution:
- 0.1 other: %wt
- No.:
- #2
- Size:
- > 200 - < 800 µm
- Distribution:
- 11.8 other: %wt
- No.:
- #3
- Size:
- > 150 - < 200 µm
- Distribution:
- 24.5 other: %wt
- No.:
- #4
- Size:
- > 100 - < 150 µm
- Distribution:
- 35.8 other: %wt
- No.:
- #5
- Size:
- > 71 - < 100 µm
- Distribution:
- 21.3 other: %wt
- No.:
- #6
- Size:
- > 63 - < 71 µm
- Distribution:
- 4 other: %wt
- No.:
- #7
- Size:
- > 40 - < 63 µm
- Distribution:
- 2.4 other: %wt
- No.:
- #8
- Size:
- > 0 - < 40 µm
- Distribution:
- 0 other: %wt
- Conclusions:
- There are no particles with diameters < 40µm. Most of the particles are > 100µm.
72.0 % wt >100 µm
0% wt < 40 µm - Executive summary:
Particle size distribution of the test material was determined with sieves according to USP method. There were no particles with diameters < 40µm. Most of the particles were > 100µm (72.0 % wt >100 µm; 0% wt < 40 µm).
In conclusion, no throracic or respirable fraction of particles is identified.
Reference
72 % of paticles are > 100 µm; 28 % of particles are in the range of 40-100 µm; 0% of the particles < 40 µm.
Description of key information
Particle size distribution was determined with sieves according to USP method. There were no particles with diameters < 40µm. Most of the particles were > 100µm (72.0 % wt >100 µm; 0% wt < 40 µm).
In conclusion, no thoracic or respirable fraction of particles could be determined.
Additional information
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