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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-10-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk
Details on test material:
This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available
Specific details on test material used for the study:
alpha-Lipoic acid (AlzChem)

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
<= 34.63 µm
Remarks on result:
other: SD not determined
Key result
Percentile:
D50
Mean:
<= 81.5 µm
Remarks on result:
other: SD not determined
Key result
Percentile:
D90
Mean:
<= 194 µm
Remarks on result:
other: SD not determined
Key result
Percentile:
D95
Mean:
<= 174.31 µm
Remarks on result:
other: SD not determined
Key result
Percentile:
other: D98
Mean:
<= 205.2 µm
Remarks on result:
other: SD not determined
Key result
Percentile:
other: D100
Mean:
<= 610 µm
Remarks on result:
other: SD not determined
Particle size distribution at different passages
No.:
#1
Remarks on result:
not measured/tested

Any other information on results incl. tables

Parameter

Result

Method

10 % of the sample

Particle size

≤ 34.63 µm

Laser Difffraction

50 % of the sample

Particle size

≤ 81.50 µm

Laser Difffraction

90 % of the sample

Particle size

≤ 149.00 µm

Laser Difffraction

95 % of the sample

Particle size

≤ 174.31 µm

Laser Difffraction

98 % of the sample

Particle size

≤ 205.20 µm

Laser Difffraction

100 % of the sample

Particle size

≤ 610.00 µm

Laser Difffraction

SMD

≤ 49.78 µm

Calculated

VMD

≤ 89.06 µm

Calculated

SV

≤ 0.12 m2/cm3

Calculated

Applicant's summary and conclusion

Conclusions:
Alpha Lipoic Acid has a SMD of 49.78 µm (Calculated)
Alpha Lipoic Acid has a VMD of 89.06 µm (Calculated)
Executive summary:

Alpha Lipoic Acid has a SMD of 49.78 µm (Calculated) 

Alpha Lipoic Acid has a VMD of 89.06 µm (Calculated)