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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:
2017/05/11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
GLP compliance:
no
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:
2,4-Diamino-6-chloropyrimidine-3-oxide
EC Number:
609-076-5
Cas Number:
35139-67-4
Molecular formula:
C4H5ClN4O
IUPAC Name:
2,4-Diamino-6-chloropyrimidine-3-oxide
Test material form:
solid
Remarks:
white/beige solid
Specific details on test material used for the study:
- Analytical purity: > 99%- Lot/batch No.: 0160405- Expiration date of the lot/batch: 21/02/2018

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 1.3 µm
St. dev.:
0
Key result
Percentile:
D50
Mean:
ca. 7.1 µm
St. dev.:
0
Percentile:
D90
Mean:
ca. 44.5 µm
St. dev.:
0.45

Any other information on results incl. tables

Particle Size Distribution

Two test series of 3 measurements each were performed with the fine fraction <2000 µm of the test item.

Test series 1:

D10:       1.3 µm

D50:       7.1 µm       (Median diameter)

D90:       44.1 µm

Test series 2:

D10:       1.3 µm

D50:       7.1 µm       (Median diameter)

D90:       45.0 µm

Average

D10:       1.3 µm

D50:       7.1 µm       (Median diameter)

D90:       44.5 µm

The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement.

Applicant's summary and conclusion

Conclusions:
The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement.
Executive summary:

The fine fraction <2000 µm of the test item MEXORYL SAG/10 lyophilisé has a median particle size D50 = 7.1 µm, which was determined by laser diffraction measurement, according to ISO13320 (2009).