Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate

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:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002).

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Identification: FAT 20242/I TE
Appearance/Physical State: Dark blue solid
Batch: AT-PD14-026A1
Purity: ≥ 85%
Expiry Date: 20 January 2019
Storage Conditions: Room temperature in the dark

Remarks on result:

not determinable

Remarks:

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

Percentile:

D50

Remarks on result:

other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

No.:

#1

Size:

< 10 µm

Distribution:

1.66 %

Remarks on result:

other: Mean cumulative percentage

No.:

#2

Size:

< 5.5 µm

Distribution:

0.17 %

Remarks on result:

other: Mean cumulative percentage

Sieve Screening Test

The results of the sieving procedure are shown in the following table:

 

Measurement	Result
Mass of test item transferred to sieve	12.85 g
Mass of test item passed through sieve	4.03 g
Percentage of test item less than 100 µm	31.4 %

 

 

Cascade Impactor

The results of the cascade impactor procedure are shown in the following table:

 

Collection Stage	Particle Size Range Collected (µm)	Collected Mass (g)
		Determination 1	Determination 2	Determination 3
Artificial throat	n/a	0.99	0.70	0.67
Cup 1	>10.0	1.7009	2.1677	2.2174
Cup 2	5.5 to 10.0	0.0304	0.0375	0.0610
Cup 3	2.4 to 5.5	0.0018	0.0032	0.0022
Cup 4	1.61 to 2.4	0.0003	0.0018	0.0005
Cup 5	0.307 to 1.61	0.0000	0.0024	0.0002
Final Filter	<0.307	0.0009	0.0007	0.0005
Total mass of collected test item		2.7243	2.9133	2.9518

 

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

 

Particle Size Cut Points (µm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0334	0.0456	0.0644	1.23	1.57	2.18
<5.5	0.0030	0.0081	0.0034	0.11	0.28	0.12
<2.4	0.0012	0.0049	0.0012	0.04	0.17	0.04
<1.61	0.0009	0.0031	0.0007	0.03	0.11	0.02
<0.307	0.0009	0.0007	0.0005	0.03	0.02	0.02

 

Mean cumulative percentage with a particle size less than 10.0 µm: 1.66

Mean cumulative percentage with a particle size less than 5.5 µm: 0.17

Conclusions:

Particle size data acquired for the test item:

The percentage of test item with an inhalable particle size <100 µm (sieve method) was found to be 31.4 %.
The percentage of test item with a thoracic particle size <10.0 µm (cascade impactor) was found to be 1.66 %.
The percentage of test item with a respirable particle size <5.5 µm (cascade impactor) was found to be 0.17%.

Executive summary:

The particle size distribution of FAT 20242/I TE has been determined using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The results are as follows:

 

The percentage of test item with an inhalable particle size <100 µm (sieve method) was 31.4 %.

The percentage of test item with a thoracic particle size <10.0 µm (cascade impactor) was 1.66 %.

The percentage of test item with a respirable particle size <5.5 µm (cascade impactor) was 0.17%.

Description of key information

The percentage of test item with an inhalable particle size <100 µm (sieve method) was found to be 31.4 %.
The percentage of test item with a thoracic particle size <10.0 µm (cascade impactor method) was found to be 1.66 %.
The percentage of test item with a respirable particle size <5.5 µm (cascade impactor method) was found to be 0.17%.

Additional information

The particle size distribution of FAT20242/I TEhas been determined using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002). The results are as follows:

 

The percentage of test item with an inhalable particle size <100 µm (sieve method) was 31.4 %.

The percentage of test item with a thoracic particle size <10.0 µm (cascade impactor) was 1.66 %.

The percentage of test item with a respirable particle size <5.5 µm (cascade impactor) was 0.17%.