(2S)-2-amino-3-[3,5-diiodo-4-(4-methoxyphenoxy)phenyl]propanoic acid

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:

20 November 2018 - 26 November 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

• CIPAC MT 59 Sieve Analysis
• CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules
• CIPAC MT 169 Tap Density of Water Dispersible Granules

Principles of method if other than guideline:

Sieve analysis consists of the quantitative separation of test item into fractions of different particle size ranges by using of machine sieving method.
The test item was weighed into a beaker (W g) and poured into the measuring cylinder and fitted the rubber bung into the cylinder without jolting.
It was carefully put in the dropping box and the timing device was started.
With the thumb and forefinger of one hand the upper part of the cylinder was held and, during 1 second it was lifted up to 25 mm height. At the beginning of the next second, the cylinder was smartly released by quickly and completely withdrawing the thumb and forefinger. 50 counted drops were completed.
Then the cylinder was removed immediately from the dropping box, the volume was noted to the nearest 1 mL (V mL).

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Key result

Percentile:

D10

Mean:

<= 250 µm

Remarks on result:

other: actually the sieve size (µm) which passes less than 10 % of the charged substance is presented.

Key result

Percentile:

D95

Mean:

<= 2 000 µm

Remarks on result:

other: actually the sieve size (µm) which passes less than 10 % of the charged substance is presented.

Conclusions:

Sieve analysis consists of the quantitative separation of test item into fractions of different particle size ranges by using of machine sieving method.

Executive summary:

Machine sieving test was carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.

The sieve size (µm) which passes less than 10 % of the charged substance is 250 µm.

The sieve size (µm) which passes more than 95 % of the charged substance is 2000µm

The mean particle size (by mass) is between 250 µm and 2000 µm.

Description of key information

Machine sieving test was carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.

The sieve size (µm) which passes less than 10 % of the charged substance is 250 µm.

The sieve size (µm) which passes more than 95 % of the charged substance is 2000µm

The mean particle size (by mass) is between 250 µm and 2000 µm.

The tap density of O-METHYL-L-DIIODOTHYRONIN was found to be 0.48 g/mL.