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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-07-13 to 2017-08-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Thai Kyowa Biotechnologies Co. Ltd. / batch 160006
- Expiration date of the lot/batch: 2018-02-22
- Purity test date:2016-03-08

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature (15 °C - 25 °C), protected from light
- Stability under test conditions: stable
-
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
Key result
Percentile:
other: L50
Mean:
274.1 µm
Remarks on result:
other: St. dev. not reported
Percentile:
other: L10
Mean:
59.1 µm
Remarks on result:
other: St. dev. not reported
Percentile:
other: L90
Mean:
663.8 µm
Remarks on result:
other: St. dev. not reported
Conclusions:
The median particle size L50 of the test item deduced from the particle size distributions was
274.1 µm.
The particle size L10 of the test item deduced from the particle size distributions was
59.1 µm.
The particle size L90 of the test item deduced from the particle size distributions was
663.8 µm.
Executive summary:

The particle size distribution of L-4-Hydroxyproline was determined by laser diffraction in a study according to OECD 110.

The median particle size L50 of the test item deduced from the particle size distributions was

                    274.1 µm.

The particle size L10 of the test item deduced from the particle size distributions was

                    59.1 µm.

The particle size L90 of the test item deduced from the particle size distributions was

                    663.8 µm.

Description of key information

The median particle size L50 of the test item deduced from the particle size distributions was

                    274.1 µm.

The particle size L10 of the test item deduced from the particle size distributions was

                    59.1 µm.

The particle size L90 of the test item deduced from the particle size distributions was

                    663.8 µm.

Additional information