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:
23 Jul - 07 Oct 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study compiled in accordance with GLP. Study material is well characterised.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: CIPAC Metthod MT59, Sieve Analysis
GLP compliance:
yes
Type of method:
sieving

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-660-8
EC Name:
-
Cas Number:
224631-15-6
Molecular formula:
Hill formula: C18H26N4O5S CAS formula: C18H26N4O5S
IUPAC Name:
(S)-2,5-dioxopyrrolidin-1-yl 2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-3-methylbutanoate

Results and discussion

Particle size
Percentile:
D50
Mean:
> 45 - < 150 µm
St. dev.:
0
Remarks on result:
other: 49.44% within this range. 39.73% of the test material was noted to have a mean diametre of <45µm(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 45 - < 150 µm
Distribution:
49.44 %
No.:
#2
Size:
< 45 µm
Distribution:
39.73 %

Applicant's summary and conclusion

Conclusions:
49.44% was within the range 45µm to 150µm. 39.73% of the test material was noted to have a mean diametre of <45µm