(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: CIPAC method 187, Fraunhofer diffraction method

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

Key result

Percentile:

D50

Mean:

7.15 µm

St. dev.:

20.2

Percentile:

D10

Mean:

0.658 µm

St. dev.:

5.2

Percentile:

D90

Mean:

658 µm

St. dev.:

23.2

Table 1: Individual results of particle size distribution measurements

Determination	Dv(10) [µm]	Dv(50) [µm]	Dv(90) [µm]
1	0.631	6.49	570
2	0.697	8.80	834
3*	0.718	10.5	939
4	0.647	6.15	568
* The values from determination number 3 were not used for calculation purposes as the laser obscuration was outside the appropriate range.

Conclusions:

The particle size distribution of the substance has been determined by laser diffraction. The median particle size was 7.15 µm with a relative standard deviation of 20.2%.

Executive summary:

The particle size distribution of the substance was determined under GLP with a laser diffraction method in accordance with CIPAC Method 187. A suitable laser diffraction apparatus was used, that used a measuring technique based on light diffraction. A laser beam was passed through a suspension of a sufficient amount of test material in air, producing a diffraction pattern that was measured and analysed by the instrument. An appropriate optical model and mathematical procedure was used to assign the proportions of the total volume to a discrete number of size classes, yielding a volumetric particle size distribution. The particle size distribution was measured in four runs, however only three runs could be used in the calculation as the laser obscuration was outside of the appropriate range in the third determination. The median particle size has been determined to be 7.15 µm with a relative standard deviation of 20.2%. The 10th and 90th percentile of the particle size have been determined to be 0.658 µm and 658 µm (5.2% and 23.2% rel. std. dev.), respectively.

Description of key information

Median particle size = 7.15 µm, relative standard deviation = 20.2% (GLP, CIPAC MT 187)