1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one

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:

11 August - 25 August 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 particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

- Analytical purity: 93.3%
- Batch N°: A14JB3442
- Expiry date: 30 September 2016
- Storage condition: at room temperature

Mass median aerodynamic diameter:

86.556 µm

Geometric standard deviation:

>= 2.804 - <= 2.848

Key result

Percentile:

D10

Mean:

21.652 µm

St. dev.:

0.188

Key result

Percentile:

D50

Mean:

86.556 µm

St. dev.:

0.846

Key result

Percentile:

D90

Mean:

286.901 µm

St. dev.:

2.664

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be fine / medium sized white powder with clusters

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 624 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

Volume weighted mean was determined to be 123.674 µm.

Average Mode was determined to be 82.356 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 624 µm.
The particle size distribution of T001036 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 123.674 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 86.556 µm, whereas the average D10, D50 and the D90 were determined to be 21.652 µm, 86.556 µm and 286.901 µm, respectively.

Description of key information

The particle size distribution of T001036 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, 2015). Visual examination at 100x magnification showed irregular shaped crystals between approximately 3 µm and 624 µm. The Mass Median Aerodynamic Diameter (MMAD) was determined to be 86.556 µm. The average D10, D50 and the D90 were determined to be 21.652 µm, 86.556 µm and 286.901 µm, respectively.