1-[2-[2-methoxy-4-(morpholin-4-yl)-5-nitroanilino]pyrimidin-4-yl]-3-phenyl-1H-pyrazole-4-carbaldehyde

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-04-2021 to 06-04-2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Version / remarks:

2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

other: Medium Volume Distribution

Test material

Test material information

Constituent 1

Reference substance name:

1-[2-[2-methoxy-4-(morpholin-4-yl)-5-nitroanilino]pyrimidin-4-yl]-3-phenyl-1H-pyrazole-4-carbaldehyde

Cas Number:

1903010-39-8

Molecular formula:

C25H23N7O5

IUPAC Name:

1-[2-[2-methoxy-4-(morpholin-4-yl)-5-nitroanilino]pyrimidin-4-yl]-3-phenyl-1H-pyrazole-4-carbaldehyde

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: solid
- Appearance: orange powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch (Lot) Number: I20ED2016
- Purity/Composition: 101.5%
- Purity test date : 2020-07-27
- Expiry date: 2022-06-06 (retest date)
- Physical Description: Orange powder

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: not indicated
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated
- Reactivity of the test material with the incubation material used (e.g. plastic ware): not indicated

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
No treatment

OTHER SPECIFICS
- Purity/Composition correction factor: Yes, correction factor is 1.0

Results and discussion

Mass median aerodynamic diameter:

10.7 µm

Geometric standard deviation:

2.502

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

2.95 µm

St. dev.:

0.026

Remarks on result:

other: standard deviation of the population

Particle size 2

Key result

Percentile:

D50

Mean:

9.1 µm

St. dev.:

0.075

Remarks on result:

other: standard deviation of the population

Particle size 3

Key result

Percentile:

D90

Mean:

22.9 µm

St. dev.:

0.298

Remarks on result:

other: standard deviation of the population

Any other information on results incl. tables

The test item proved to be homogeneously and well dispersed in Milli-Ro water and therefore this solvent was used as the dispersant in the Laser Diffraction Analysis.

The particle size distribution of the test item was analysed over the range 0.01 µm to 3500 µm. The coefficient of variation for D50 is less than 3%, and for D10 and D90 is less than 5%. It can be concluded that the repeatability of the measured particle size distributions is within the acceptable limits.

53.6 % by volume of sample was seen to be < 10.00 μm

Applicant's summary and conclusion

Conclusions:

The D50 of the test item was determined to be 9.10 µm, the D10 was 2.95 µm and the D90 was 22.9 µm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 10.7 µm.