2-Pyridinecarbonitrile, 5-amino-3-(trifluoromethyl)-

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 SEP 2022 to 09 DEC 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2023

Report date:

2023

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2020

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction, Handbook K

Version / remarks:

2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-3-(trifluoromethyl)pyridine-2-carbonitrile

EC Number:

815-137-9

Cas Number:

573762-62-6

Molecular formula:

C7H4F3N3

IUPAC Name:

5-amino-3-(trifluoromethyl)pyridine-2-carbonitrile

Details on test material:

- Appearence : Slightly yellowish brown fine powder
- CAS Number: 573762-62-6
- Molecular formula: C7H4F3N3
- Molecular weight: 187.12

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch number of test material: 22CN32583
- Expiry date: 30 March 2024 (retest date)
- Physical Description: slightly yellowish brown powder (determined by Charles River Den Bosch)
- Purity: 100.6%
- Purity correction factor: not required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: not indicated
- Stability under test conditions: not indicated
- Solubility and stability of the test item in the solvent/vehicle: not relevant
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): no treatment

Results and discussion

Mass median aerodynamic diameter:

262.3 µm

Geometric standard deviation:

1.876

Particle size

Particle size 1

Percentile:

D10

Mean:

94.1 µm

St. dev.:

1.8

Particle size 2

Key result

Percentile:

D50

Mean:

208 µm

St. dev.:

3.77

Particle size 3

Percentile:

D90

Mean:

416 µm

St. dev.:

15.1

Any other information on results incl. tables

In the preliminary test, the substance was concluded to be visually insoluble in the dispersant, thus only dispersibility was investigated in the main test.

The test material proved to be homogeneously and well dispersed in Milli-Ro water with some droplets of Tween 20, and therefore this solvent was used as the dispersant in the Laser Diffraction Analysis.

The particle size distribution of the test material was analysed over the range 0.01 µm to 1400 µm.

The coefficient of variation for D50 is less than 2.5%, for D10 less than 3% and for D90 less than 4%. It can be concluded that the repeatability of the measured particle size distribution is within the acceptable limits.

Applicant's summary and conclusion

Conclusions:

The particle size distribution of JNJ-61232574-AAA (T003630) was determined by means of Laser Diffraction Analysis using the Hydro MV wet module.
The D50 of the test material was determined to be 208 µm, the D10 was 94.1 µm and the D90 was 416 µm. The MMAD of the test material, for the relative density and the mean D50, was calculated to be 262.3 µm.