Dl-Proline, 5-oxo-, compd. with N2-coco acyl-l-arginine Et ester

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:

30 March 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:

primary particle

Type of distribution:

mass based distribution

Specific details on test material used for the study:

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

Mass median aerodynamic diameter:

79.033 µm

Geometric standard deviation:

0.4

Key result

Percentile:

D50

Mean:

< 72.541 µm

St. dev.:

0.7

Remarks on result:

other: St. dev is a %

No.:

#1

Size:

< 10 µm

Distribution:

10.7 %

Table 1: Full test results

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	Average**
Volume weighted mean	87.761	87.465	86.633	87.494	88.724	87.616
Median	72.429	72.646	71.800	72.407	73.441	72.541
Mode	110.697	111.185	108.824	109.177	110.865	110.130
MMAD*	78.911	79.148	78.226	78.887	80.014	79.033
d10 - 10 % of material is <	9.423	9.473	9.387	9.405	9.478	9.433
d50 - 50 % of material is <	72.429	72.646	71.800	72.407	73.441	72.541
d90 - 90 % of material is <	191.243	189.887	188.257	190.270	192.250	190.385

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.

10.70 % by volume of sample was seen to be < 10.00 μm.

 

Table 2: Standard deviation results

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	STDVP	% STDVP
d10 - 10 % of material is <	9.423	9.473	9.387	9.405	9.478	0.036	0.4
d50 - 50 % of material is <	72.429	72.646	71.800	72.407	73.441	0.529	0.7
d90 - 90 % of material is <	191.243	189.887	188.257	190.270	192.250	1.342	0.7
d15.78 - 15.78 % of material is <	14.665	14.768	14.583	14.636	14.773	0.075	0.5
GSD	4.939	4.919	4.924	4.947	4.971	0.019	0.4
MMAD	78.911	79.148	78.226	78.887	80.014	0.577	0.7

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

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 test standard.

Conclusions:

Under the conditions of the study the MMAD was 79.033 µm and the D50 was 72.541 µm.

Executive summary:

The particle size of the test material was determined in accordance with the standardised guideline ISO:133220 under GLP conditions using microscopic examination and laser diffraction.

Following solubility testing it was determined that acetone would be used as a dispersant for the test material. The particle size was analysed over the range 0.02 μm to 2 000 μm and 5 runs were performed to ensure reliability of results.

Coefficient of variation for D50 was 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 test standard.

The volume of sample < 10 µm was 10.7 %.

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.

Description of key information

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.

Additional information

The particle size of the test material was determined in accordance with the standardised guideline ISO:133220 under GLP conditions using microscopic examination and laser diffraction.

Following solubility testing it was determined that acetone would be used as a dispersant for the test material. The particle size was analysed over the range 0.02 μm to 2 000 μm and 5 runs were performed to ensure reliability of results.

Coefficient of variation for D50 was 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 test standard.

The volume of sample < 10µm was 10.7 %.

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.