Tetrasodium {5-[(4-chloro-6-{[4-(alkenylsulfonyl)phenyl]amino}-heteromonocycl-2-yl)amino]-4-(hydroxy-κO)-3-{[2-(hydroxy-κO)phenyl]diazenyl-κN}naphthalene-disulfonato(4-)}[3-(hydroxy-κO)-4-{[2-(hydroxy-κO)naphthalen-1-yl]diazenyl-κN}naphthalene-sulfonato(3-)]chromate(4-)

Particle size distribution (Granulometry)

Description of key information

Determination of the particle size experiment on the raw material (FAT 40863/A TE) and on the final product (trade form; FAT 20341/B TE).

Additional information

The experiment (performed by Siemens), was performed on the final product (trade form).

The median particle size L₅₀of the test item deduced from the particle size distributions is 144.73 µm.

The particle size L₁₀of the test item deduced from the particle size distributions is 78.59 µm.

The particle size L₉₀of the test item deduced from the particle size distributions is 257.09 µm.

The average cumulative partition of the particle size≤10 µm is 0 Vol %.

The mass median aerodynamic diameter MMAD is 144.73 µm.

The geometric standard deviation GSD is 1.6 µm.

The second experiment was performed on the raw material by HARLAN on (FAT 40863/A TE)

The method used a procedure designed to be compatible with European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002).

  

Measurement		Method		Result
Proportion of test item having an inhalable particle size <100 µm		Sieve		~ 100 %*
Proportion of test item having a thoracic particle size <10.0 µm		Cascade Impactor		≤1.827 %
Proportion of test item having a respirable particle size <5.5 µm		Cascade Impactor		≤0.700 %

 

*After testing, the sieve and sieve base were inspected and found to be contaminated with a liquid. However, it was noted that the test item had essentially passed through the sieve.