Copper di-D-gluconate

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:

2018

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:

The test is conducted in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

At the request of the sponsor the test item was dried prior to testing. This was performed
by initially vacuum drying by means of a rotary evaporator until the sample had become a
paste. The sample was then placed on trays and allowed to stand under ambient
conditions for 4 days to remove solvent/ moisture. The trays were then placed in drying
ovens at 50°C for 16 hours until constant weight had been achieved.

Mass median aerodynamic diameter:

9.096 µm

Geometric standard deviation:

2.234

Key result

Percentile:

D50

Mean:

6.82 µm

St. dev.:

0.034

Percentile:

D10

Mean:

3.65 µm

St. dev.:

0.01

Percentile:

D90

Mean:

17.1 µm

St. dev.:

0.812

For detailed results (distribution of different passages) see attached file results.

Conclusions:

The mass median aerodynamic diameter (MMAD) of the substance is 9.096 µm, the particle size distribution ranges from 0.01 to 3500 µm. 75.14 % by volume of sample was seen to be < 10.00 μm.
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.

Description of key information

The mass median aerodynamic diameter (MMAD) of the substance is 9.096 µm, the particle size distribution ranges from 0.01 to 3500 µm. 75.14 % by volume of sample was seen to be < 10.00 μm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.