Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

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:

Experiment start and end date - 14 August 2006; Study completion date - 21 September 2006.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: "Particle size distribution, fibre length and diameter distribution" guidance document, ECB/TM/Feb. 1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: "Particle size distribution, fibre length and diameter distribution" draft guidance document, EUR 20268 EN (2002), Part 5.2 "Laser scattering/diffraction"

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

mass based distribution

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Percentile:

D50

Mean:

< 5.5 µm

St. dev.:

0.067

Remarks on result:

other: 50 % of the total sample mass is presented in particles having a diameter smaller than 5.5 µm.

No.:

#1

Size:

< 1.3 µm

Distribution:

5 %

Remarks on result:

other: sd. 0.018

No.:

#2

Size:

< 1.9 µm

Distribution:

10 %

Remarks on result:

other: sd. 0.028

No.:

#3

Size:

< 5.5 µm

Distribution:

50 %

Remarks on result:

other: sd. 0.067

No.:

#4

Size:

< 11.8 µm

Distribution:

90 %

Remarks on result:

other: sd. 0.259

No.:

#5

Size:

< 24 µm

Distribution:

100 %

Remarks on result:

other: sd. 0

Conclusions:

The mass median diameter (MMD) of FAT 40827/A was determined to be <5.5 µm.

Executive summary:

The determination of the particle size distribution of FAT 40827/A was performed according to the European Commission, Part 5.2 "Laser scattering / diffraction" using the laser diffraction method. FAT 40827/A is a fine black powder. Under the microscope (with a magnification of 400) black globules of different sizes were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40827/A was performed with two samples of the stock dispersion each measured in duplicate. The individual measurements and the results obtained using the laser diffraction method of FAT 40827/A were determined. In conclusion, using the laser diffraction method to study the particle size of FAT 40827/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be <5.5 µm. The particle size distribution was found to range from approximately 0.3 µm to 24.0 µm.

Description of key information

 The mass median diameter (MMD) of FAT 40827/A was determined to be <5.5 µm. 

Additional information

The determination of the particle size distribution of FAT 40827/A was performed according to the European Commission, Part 5.2 "Laser scattering / diffraction" using the laser diffraction method. FAT 40827/A is a fine black powder. Under the microscope (with a magnification of 400) black globules of different sizes were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40827/A was performed with two samples of the stock dispersion each measured in duplicate. The individual measurements and the results obtained using the laser diffraction method of FAT 40827/A were determined. In conclusion, using the laser diffraction method to study the particle size of FAT 40827/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be <5.5 µm The particle size distribution was found to range from approximately 0.3 µm to 24.0 µm.