Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 10, 2016 - October 21, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC method MT 59 and MT 170
Deviations:
no
Principles of method if other than guideline:
The certified sieves were assembled in the correct order with the coarsest at the top and the finest at the bottom and mounted on the receiver pan. Using the technical balance, 50.08 g of the dry test item was weighed and placed into the coarsest sieve. The lid was fitted to the nest of sieves and it was put into the shaking apparatus.
The shaker was started and run for 5 minutes. That time elapsed, the sieves were removed and the test item in each sieve was weighed again on the technical balance.

The residue was calculated using the following equation:

gx
rx (%) = _______ x 100
m

where:
rx= Residue on each sieve x (%)
gx= Amount of the sample retained by the sieve x (g)
m= Weight of the sample (g)

The total residue on all x sieves was then calculated by the following equation:

Rx = Sum of rx on all coarser sieves
GLP compliance:
no
Other quality assurance:
other:
Remarks:
not specified
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Internal sample code: 2929564-001
Purity: 100.3% w/w
Batch number: 2510468
Mass median aerodynamic diameter:
other: Particle size distribution
Remarks on result:
other: Particle size distribution
Remarks:
Particle size distribution
Key result
Remarks on result:
other: Particle size distribution
Remarks:
Particle size distribution
Remarks on result:
other: Particle size distribution
Remarks:
Particle size distribution
Conclusions:
The hygroscopic nature of the test item may have effects on the results of particle size distribution.
From the obtained experimental data according to CIPAC method MT 59 and MT 170, it can be concluded that, after 5 minutes of shaking, the particle size distribution of Delmopinolo HCl is:
- 65.10% of the sample presents a particle size higher than 0.710 mm (710 um)
- 96.45% of the sample presents a particle size higher than 0.500 mm (500 um)
- 99.50% of the sample presents a particle size higher than 0.355 mm (355 um)
- 99.72% of the sample presents a particle size higher than 0.250 mm (250 um)
- 99.83% of the sample presents a particle size higher than 0.125 mm (125 um)
- 99.87% of the sample presents a particle size higher than 0.075 mm (75 um)
- 0.02% of the sample was found under 0.045 mm (45 um).


Executive summary:

Particle Size Distribution:

- About 95% > (500 mm)

- About 99% > (45 mm)

Description of key information

From the obtained experimental data according to CIPAC method MT 59 and MT 170, it can be concluded that, after 5 minutes of shaking, the particle size distribution of Delmopinolo HCl is:

- 65.10% of the sample presents a particle size higher than 0.710 mm (710 um)

- 96.45% of the sample presents a particle size higher than 0.500 mm (500 um)

- 99.50% of the sample presents a particle size higher than 0.355 mm (355 um)

- 99.72% of the sample presents a particle size higher than 0.250 mm (250 um)

- 99.83% of the sample presents a particle size higher than 0.125 mm (125 um)

- 99.87% of the sample presents a particle size higher than 0.075 mm (75 um)

- 0.02% of the sample was found under 0.045 mm (45 um).

Additional information

Particle Size Distribution:

-About 95% > (500 mm)

-About 99% > (45 mm)