Reaction mass of L-Glutamic acid, N-coco acyl derivs., monosodium salts and sodium hydrogen N-(1-oxooctadecyl)-L-glutamate

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:

17 August 2016 to 19 December 2016

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

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

Mass median aerodynamic diameter:

45.275 µm

Geometric standard deviation:

0.003

Key result

Percentile:

D50

Mean:

< 60.367 µm

St. dev.:

0.186

Optical Microscope Analysis

Standard visual observation: Sample observed to contain fine, medium and coarse, particles of white powder with clusters and agglomerations.

Observation at 100 x magnification: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 144 μm.

Observation at 400 x magnification: The sample was observed to be made up of both single crystalline particles and agglomerated particles.

 

Manual Sieve Analysis

Manual sieve analysis indicated that 82.5 % by weight of the sample had a particle size of < 500 μm.

 

Laser Diffraction Analysis

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

Results can be seen in Tables 1 and 2.

Table 1: Summary of Test Results

Result	Average result (µm) of 5 runs
Volume weighted mean	93.473
Median	60.367
Mode	58.894
Mass median aerodynamic diameter (MMAD)	45.275
d10 - 10 % of material is <	20.858
d50 - 50 % of material is <	60.367
d90 - 90 % of material is <	202.378

 2.67 % by volume of sample was see to be < 10.0 µm.

Table 2: Summary of standard deviation results

Result	Standard deviation of the population (STDVP)	%STDVP
d10 - 10 % of material is <	0.053	0.3
d50 - 50 % of material is <	0.186	0.3
d90 - 90 % of material is <	3.376	1.7
d15.78 - 15.78 % of material is <	0.062	0.2
Geometric standard deviation (GSD)	0.003	0.1
Mass median aerodynamic diameter (MMAD)	0.14	0.3

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.

Conclusions:

Under the conditions of this study the MMAD of the test material was 45.275 µm and the D50 was < 60.367 µm.

Executive summary:

The particle size of the test material was investigated in accordance with the standardised guideline ISO 13320:2009 and CIPAC MT 187 under GLP conditions.

Following from optical microscope analysis and manual sieve analysis, laser diffraction was performed.

Under the conditions of this study the MMAD of the test material was 45.275 µm and the D50 was < 60.367 µm.

Description of key information

Under the conditions of this study the MMAD of the test material was 45.275 µm and the D50 was < 60.367 µm.

Additional information

The particle size of the test material was investigated in accordance with the standardised guideline ISO 13320:2009 and CIPAC MT 187 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Following from optical microscope analysis and manual sieve analysis, laser diffraction was performed.

Under the conditions of this study the MMAD of the test material was 45.275 µm and the D50 was < 60.367 µm.