Registration Dossier

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:
November 21, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with ISO 13320:2009 and CIPAC MT 187.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Strontium Tartrate (anhydrous)
- Appearance: Off-white powder

Results and discussion

Mass median aerodynamic diameter:
248.311 - 254.766 µm
Geometric standard deviation:
1.827 - 1.841
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:
74.277 µm
St. dev.:
0.941
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
166.338 µm
St. dev.:
1.608
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D90
Mean:
310.931 µm
St. dev.:
3.888
Remarks on result:
other: Population standard deviation [µm]
Particle size distribution at different passages
Size:
< 10 µm
Distribution:
0.24 %
Remarks on result:
other: By volume

Any other information on results incl. tables

MMAD mean: 250.062 µm (population standard deviation: 2.42 µm)

Mode: 182.532 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:
In a GLP-compliant study in accordance with ISO 13320:2009 and CIPAC MT 187 using the laser diffraction analysis dry powder module, the particle size distribution of the substance was determined as follows: 0.24% is < 10.00 µm; 10% is < 74.3 µm; 50% is < 166.3 µm and 90% is < 310.9 µm. The MMAD is 250.1 µm.