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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:
06 March, 2013 - 12 March, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Principles of method if other than guideline:
OECD 110 was taken into consideration.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
EC Number:
215-947-7
EC Name:
Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
Cas Number:
1458-18-0
Molecular formula:
C6H5Cl2N3O2
IUPAC Name:
methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
Test material form:
solid: particulate/powder
Details on test material:
Identification: Amiloride Compound 7
Molecular formula: C6H5Cl2N3O2
Molecular weight: 222.03
CAS Number:1458-18-0
Description: Tan powder
Batch: 206-2
Purity/Composition: 99.7 area%
Test substance storage: In refrigerator (2-8°C) protected from light, desiccated
Stability under storage conditions: Stable
Expiry date: 11 May 2014 (Retest date)

Results and discussion

Mass median aerodynamic diameter:
>= 125.998 - <= 126.658 µm
Geometric standard deviation:
>= 1.757 - <= 1.762
Particle sizeopen allclose all
Percentile:
D10
Mean:
42.564 µm
St. dev.:
0.13
Percentile:
D50
Mean:
95.508 µm
St. dev.:
0.16
Percentile:
D90
Mean:
165.803 µm
St. dev.:
0.29
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 10 µm
Distribution:
0.17 %
No.:
#2
Size:
< 43 µm
Distribution:
<= 10 %
No.:
#3
Size:
< 96 µm
Distribution:
<= 50 %
No.:
#4
Size:
< 166 µm
Distribution:
<= 90 %

Any other information on results incl. tables

MMAD mean: 126.345 µm

Volume weighted mean: 100.359 µm

Mode: 103.723 µm

 

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the substance was determined by laser diffraction analysis-'wet' small volume dispersion method (in accordance with ISO 13320 and CIPAC MT 187 and in compliance with GLP); MMAD= 126 µm; 0.2% is < 10 µm; 10% is < 43 µm; 50% is < 96 µm and 90% is < 166 µm.