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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:
06 March 2013 - 11 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed in accordance with the ISO 13320:2009 and CIPAC MT 187 guidelines and complied with the principles of GLP.

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
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:
3-aminopyrazine-2-carboxylic acid
EC Number:
226-558-7
EC Name:
3-aminopyrazine-2-carboxylic acid
Cas Number:
5424-01-1
Molecular formula:
C5H5N3O2
IUPAC Name:
3-aminopyrazine-2-carboxylic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Amiloride Compound 5
- Description: Tan powder
- Storage condition of test material: In refrigerator protected from light, desiccated.
- Other: Sample is hygroscopic and reactive to light and oxygen

Results and discussion

Mass median aerodynamic diameter:
ca. 78.977 - ca. 80.645 µm
Geometric standard deviation:
ca. 2.413 - ca. 2.484
Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
20.396 µm
St. dev.:
0.07
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
62.671 µm
St. dev.:
0.53
Remarks on result:
other: Population standard deviation [µm]. Median.
Percentile:
D90
Mean:
288.436 µm
St. dev.:
2.33
Remarks on result:
other: Population standard deviation [µm]
Particle size distribution at different passages
No.:
#1
Size:
ca. < 10 µm
Distribution:
1.93 %

Any other information on results incl. tables

MMAD mean: 79.768 µm

Volume weighted mean: 111.064 µm

Mode: 46.603 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= 80 µm; 2% is < 10 µm; 10% is < 20 µm; 50% is < 63 µm and 90% is < 288 µm.