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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 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 more than 95 % 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 1000µm

The mean particle size (by mass) is between 250 µm and 1000 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 1000µm

The mean particle size (by mass) is between 250 µm and 1000 µm.

The tap density of Levothyronine Acid was found to be 0.48 g/mL.

Additional information