2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]

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:

9 July 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed to ISO standard in accordance with GLP and reported with a GLP certificate.

Qualifier:

according to guideline

Guideline:

other: ISO 13320:2009

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Mass median aerodynamic diameter:

0.777 µm

Geometric standard deviation:

> 1.782 - < 1.785

Percentile:

D50

Mean:

0.731 µm

St. dev.:

0.002

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Percentile:

D50

Mean:

0.731 µm

St. dev.:

0.002

Percentile:

D10

Mean:

< 0.355 µm

St. dev.:

0.001

Percentile:

D90

Mean:

< 2.319 µm

St. dev.:

0.104

Full Test Results

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	**Average
Volume weight Mean	1.428	1.434	1.432	1.438	1.435	1.433
Median (d.50)	0.729	0.731	0.730	0.732	0.731	0.731
Mode (μm)	0.678	0.678	0.678	0.679	0.678	0.678
*MMAD	0.775	0.777	0.776	0.779	0.777	0.777
10% of material is <	0.355	0.355	0.355	0.356	0.355	0.355
50% of material is <	0.729	0.731	0.730	0.732	0.731	0.731
90% of material is <	2.256	2.315	2.315	2.360	2.357	2.319

All results are in μm

*Mass Median Aerodynamic Diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

97.78% by volume of sample was seen to be < 10.00 μm

 

Standard Deviation Results

Run No.	1	2	3	4	5	STDVP	%STDVP
d10	0.355	0.355	0.355	0.356	0.355	0.000	0.1
d50	0.729	0.731	0.730	0.732	0.731	0.001	0.1
d90	2.256	2.315	2.312	2.360	2.357	0.038	1.6
d15.78	0.409	0.410	0.409	0.410	0.410	0.000	0.1
GSD	1.782	1.783	1.785	1.785	1.783	0.001	0.1
MMAD	0.78	0.78	0.78	0.78	0.78	0.00	0.2

GSD = Geometric standard deviation

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Conclusions:

97.78 % by volume of sample was seen to be < 10.00 μm.

Executive summary:

The results of the laser diffraction test conducted to determine the particle size of the sample are summarised in the table below. The analysis was conducted using the dry powder module (DPM).

97.78 % by volume of sample was seen to be < 10.00 μm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

 

Summary of results

Particle Size Analysis using dry powder module (DPM)	Average (μm)
Volume weighted mean	1.433
Median (d.50)	0.731
Mode	0.678
MMAD (Mass Median Aerodynamic Diameter)	0.777
10% of material is <	0.355
50% of material is <	0.731
90% of material is <	2.319
Volume of sample < 10.00 μm	97.78%

 

Description of key information

Key value determined at a GLP accredited laboratory.

97.78 % by volume of sample was seen to be < 10.00 μm.