2-({2-[4-(dimethylamino)benzoyloxy]ethyl}(methyl)amino)ethyl 4-(dimethylamino)benzoate

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:

08 April 2019 - 17 April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Version / remarks:

Particle Size Analysis by Laser Diffraction, Handbook K. 2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Identification: Esacure A198
Physical Description: White powder
Purity/Composition: 99.2%
Storage Conditions: At room temperature protected from light desiccated

Mass median aerodynamic diameter:

1 870 µm

Geometric standard deviation:

2.289

Percentile:

D50

Mean:

1 700 µm

St. dev.:

28.1

Percentile:

D10

Mean:

894 µm

St. dev.:

29.9

Percentile:

D90

Mean:

2 710 µm

St. dev.:

32.6

The particle size distribution of the test item was analysed over the range 0.01 µm to 3500 µm. Due to relatively large particles and limitations of the system the volume % of the fraction >3500 µm cannot be determined.

The results of the analysis are presented below.

	Run 1	Run 2	Run 3	Run 4	Run 5	Mean	STDVP	%STDVP
Volume weighted mean	1780	1740	1730	1700	1720	1740	30.5	1.76
Mode	1910	1870	1880	1820	1820	1860	40.1	2.16
d10 (10% of material is <)	935	909	868	863	898	894	29.9	3.35
d50 (50% of material is <)	1740	1710	1700	1660	1680	1700	28.1	1.65
d90 (90% of material is <)	2760	2710	2720	2680	2690	2710	32.6	1.2
GSD	2.146	2.283	2.375	2.359	2.282	2.289	0.091	3.956
MMAD	1870

All results are in µm.

Definitions

GSD                     geometric standard deviation of the lognormal particle size distribution

MMAD              mass median aerodynamic diameter

Mean                     Calculated from the entirety of the data captured in each run and not a                     simple arithmetic mean

STDVP              standard deviation of the population

%STDVP              percentage standard deviation of the population

The coefficient of variation for d50 is less than 3%, d10 and d90 are less than 5%. It can be concluded that the repeatability of the characteristic particles in the size distribution are within the acceptable limits.

Conclusions:

The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM).
The D50 of the test item was determined to be 1700 µm, the D10 was 894 µm and the D90 was 2710 µm. The MMAD of the test item was calculated to be 1870 µm.

Executive summary:

The objective of this study was to determine the particle size distribution of Esacure A198.

The summary of the results is listed below:

Particle Size Analysis using medium volume (wet) module (MVM)	Average (µm)
Volume weighted mean	1740
Mode	1860
D10 (10% of material is <)	894
D50 (50% of material is <)	1700
D90 (90% of material is <)	2710
MMAD (mass median aerodynamic diameter)	1870
Volume of sample <10.00 µm	0.12% (<9.86 µm)

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

Additional information

MMAD: 1870 µm