cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride

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:

12 August - 04 December 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

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

- Batch n°: I14KB4717
- Analytical purity: 105.7% (acid titration)
- Expiration date: 25 November 2016
- Storage condition: at room temperature

Mass median aerodynamic diameter:

22.666 µm

Percentile:

D10

Mean:

6.791 µm

St. dev.:

0.014

Percentile:

D50

Mean:

18.089 µm

St. dev.:

0.029

Percentile:

D90

Mean:

34.844 µm

St. dev.:

0.098

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a medium and fine white powder with clusters.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 64 µm)

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

Average volume weighted mean was determined to be 19.676 µm.

Average mode was determined to be 19.433 µm.

The Coefficient of Variation (CV) for d50 wass <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 64 µm.
The particle size distribution of T001202 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 19.676 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 22.666 µm, whereas the average D10, D50 and the D90 were determined to be 6.791 µm, 18.089 µm and 34.844 µm, respectively.

Description of key information

The particle size distribution of T001202 was determined by the laser diffraction method in a Klimisch 1 GLP study according to the Chilworth Technology Ltd SOP n°417, ISO 13320:2009 and CIPAC MT 187 (Chilworth Technology Limited, 2016).

Visual examination at 100x magnification showed irregular shaped crystals between approximately 3 and 64 µm.

The Mass Median Aerodynamic Diameter (MMAD) was determined to be 22.666 µm. The average D10, D50 and the D90 were determined to be 6.791 µm, 18.089 µm and 34.844 µm, respectively.