2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 August 2015 - 10 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: ISO 13320-1

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

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

Specific details on test material used for the study:

- Batch n°: M14IB5308
- Analytical purity: 99.6%
- Expiration date: 03 February 2016
- Storage condition: at room temperature

Mass median aerodynamic diameter:

230.221 µm

Geometric standard deviation:

>= 2.096 - <= 2.133

Percentile:

D10

Mean:

69.561 µm

St. dev.:

0.303

Percentile:

D50

Mean:

187.975 µm

St. dev.:

1.174

Percentile:

D90

Mean:

372.374 µm

St. dev.:

2.927

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a coarse, medium size, off-white powder with clusters

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 656 µm)

(3) 400x magnification: sample was observed to be made up of single crystalline particles

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in silicone oil. Therefore, silicone oil was used as the suspension fluid.

Laser Diffraction Particle Size Analysis

The volume weighted mean was determined to be 206.177 µm.

The average Mode was determined to be 225.177 µm.

The coefficient of variation for d50 was < 3%. For d10 and d90 it was < 5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.

Conclusions:

Visual examination at 100x magnification showed irregular shaped crystals between approximately 3 µm and 656 µm.
The particle size distribution of T001159 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 206.177 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 230.221 µm, whereas the average D10, D50 and the D90 were determined to be 69.561 µm, 187.975 µm and 372.374 µm, respectively.

Description of key information

The particle size distribution (PSD) of T001159 was determined by a GLP study according to the methods ISO 13320:2009 and CIPAC MT 187 (K1, Livingston, 2016) using the laser diffraction method.

The visual examination at 100x magnification showed irregular shaped crystals between approximately 3 µm and 656 µm.

The mass median aerodynamic diameter (MMAD) was determined to be 230.221 µm, whereas the average D10, D50 and D90 were determined to be 69.561 µm, 187.975 µm and 372.374 µm, respectively.