1-(3,5-Dihydroxyphenyl)-1-oxo-2-(N-1-(4-methoxyphenyl)isopropylamino)ethane Hydrobromide

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 1 - 7, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Principles of method if other than guideline:

recognized international standard

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

1-(3,5-dihydroxyphenyl)-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethan-1-one hydrobromide

EC Number:

928-779-0

Cas Number:

1178555-23-1

Molecular formula:

C18-H21-N-O4 x HBr

IUPAC Name:

1-(3,5-dihydroxyphenyl)-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethan-1-one hydrobromide

Test material form:

solid: particulate/powder

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D50

Mean:

6.62 µm

Remarks on result:

other: Mean of three measurements 6.705 µm, 6.610 µm and 6.537 µm

Particle size 2

Percentile:

D10

Mean:

1.62 µm

Remarks on result:

other: Mean of three measurements 1.637 µm, 1.614 µm and 1.596 µm

Particle size 3

Percentile:

D90

Mean:

26.55 µm

Remarks on result:

other: Mean of three measurements 26.732 µm, 26.570 µm and 26.388 µm

Applicant's summary and conclusion

Conclusions:

The L10 D (v, 0.1) was determined to be 1.62 µm, the L50 D (v, 0.5) was determined to be 6.62 µm and the L90 D (v, 0.9) was determined to be 26.55 µm.