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Diss Factsheets

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:
May 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
EC Number:
272-296-1
EC Name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
Cas Number:
68797-35-3
Molecular formula:
C42H62O16.2K
IUPAC Name:
α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt

Results and discussion

Mass median aerodynamic diameter:
ca. 41.921 µm
Geometric standard deviation:
ca. 2.206
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 11.9 µm
St. dev.:
0.009
Key result
Percentile:
D50
Mean:
ca. 37.1 µm
St. dev.:
0.052
Key result
Percentile:
D90
Mean:
ca. 82.3 µm
St. dev.:
0.377

Applicant's summary and conclusion

Executive summary:

The results of the laser diffraction test conducted to determine the particle size of Dipotassium Glycyrrhizate (ISO 13320:2009 “Particle Size Analysis – Laser Diffraction

Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007) are summarised in the table below. The analysis was conducted using the dry powder module (DPM).

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

42.8

Mode

44.1

d10 (10 % of material is <)

11.9

d50 (50 % of material is <) (median)

37.1

d90 (90 % of material is <)

82.3

MMAD (mass median aerodynamic diameter)

41.921

Volume of sample < 10.00 μm

7.64%