Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- yes
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- counted distribution
Test material
- Reference substance name:
- 2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
- Molecular formula:
- (C14H19Na2NO14S)n
- IUPAC Name:
- 2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- >= 49.3 - <= 209.1 µm
- Remarks on result:
- not determinable because of methodological limitations
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 2 µm
- Distribution:
- ca. 1.04 %
- No.:
- #1
- Size:
- >= 2 - <= 200 µm
- Distribution:
- ca. 72.59 %
- No.:
- #1
- Size:
- >= 200 µm
- Distribution:
- ca. 26.37 %
Any other information on results incl. tables
Using abinocular magnifier, the substance was visually confirmedas being a powder, not a fibre.
Three measurements were performed under acetone medium.
Applicant's summary and conclusion
- Conclusions:
- The particle size distribution of the test item SODIUM CHONDROITIN SULFATE has been determined and the following results were obtained:
-1.04 % of particles own a diameter under 2 µm.
-72.59 % of particles own a diameter between 2 µm and 200 µm.
-26.37 % of particles own a diameter over 200 µm.
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