(S)-N,N'-dibutyl-2-[(1-oxododecyl)amino]glutaramide

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:

05 April 2017

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:

other: Single crystalline particles and agglomerated particles

Type of distribution:

mass based distribution

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature in a dark storeroom.

Mass median aerodynamic diameter:

237.257 µm

Geometric standard deviation:

8.265

Key result

Percentile:

D10

Mean:

< 14.573 µm

St. dev.:

0.143

Key result

Percentile:

D50

Mean:

< 236.784 µm

St. dev.:

3.951

Key result

Percentile:

D90

Mean:

< 542.634 µm

St. dev.:

9.809

No.:

#1

Size:

< 10 µm

Distribution:

< 7.17 %

Table 1: Summary of results

Particle Size Analysis using dry powder module (DPM)	Average (μm)
Volume weighted mean	257.671
Median	236.784
Mode	379.873
MMAD (mass median aerodynamic diameter)	237.257
d10 - 10 % of material is <	14.573
d50 - 50 % of material is <	236.784
d90 - 90 % of material is <	542.634
Volume of sample < 10.00 μm	7.17 %

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a fine to medium, free flowing, white powder with lumps and clusters.

- Observation using 3.2 objective lens: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 384 μm.

- Observation using 40 objective lens: The sample was observed to be made up of single crystalline particles and agglomerated particles.

Repeatability

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

Conclusions:

Under the conditions of this study the MMAD was 237.257 µm.

Executive summary:

The particle size distribution of the test material was determined in accordance with the standardised guidelines ISO:13320 and CIPAC MT 187, under GLP conditions. The test was performed using laser diffraction.

Under the conditions of this study the MMAD was 237.257 µm. D10 was < 14.573 µm, D50 was < 236.784 µm and D90 was < 542.634 µm. 7.17 % by volume of the sample was seen to be < 10.0 µm.

Repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Description of key information

Under the conditions of this study the MMAD was 237.257 µm.

Additional information

The particle size distribution of the test material was determined in accordance with the standardised guidelines ISO:13320 and CIPAC MT 187, under GLP conditions. The test was performed using laser diffraction.

Under the conditions of this study the MMAD was 237.257 µm. D10 was < 14.573 µm, D50 was < 236.784 µm and D90 was < 542.634 µm. 7.17 % by volume of the sample was seen to be < 10.0 µm.

Repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.