N-phenyl-N-piperidin-4-ylpropionamide

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 April - 21 April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 13320-1

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

N-phenyl-N-piperidin-4-ylpropionamide

EC Number:

216-543-3

EC Name:

N-phenyl-N-piperidin-4-ylpropionamide

Cas Number:

1609-66-1

Molecular formula:

C14H20N2O

IUPAC Name:

N-phenyl-N-piperidin-4-ylpropionamide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): JNJ-1594255-AAA (T000425)
- Physical state: solid (powder)
- Appearance: white

Specific details on test material used for the study:

- Batch n°: I15KB4578
- Analytical purity: 99.3% (base titration)
- Expiration date: 26 November 2017
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:

280.051 µm

Geometric standard deviation:

>= 2.338 - <= 2.374

Particle size

Particle size 1

Percentile:

D10

Mean:

77.729 µm

St. dev.:

0.666

Particle size 2

Percentile:

D50

Mean:

261.149 µm

St. dev.:

4.126

Particle size 3

Percentile:

D90

Mean:

517.698 µm

St. dev.:

4.875

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a fine to medium, white powder with some clusters and agglomerations.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 13 µm and largest +/- 656 µm).

(3) 400x magnification: sample was observed to be made up of single crystalline particles.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 283.097 µm.

Average mode was determined to be 315.126 µm.

The Coefficient of Variation (CV) for d50 wass <3%. For d10 and d90 it was <5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:

Visual examination at 100x magnification showed irregular shaped crystals between approximately 13 µm and 656 µm.
The particle size distribution of T000425 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 283.097 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 280.051 µm, whereas the average D10, D50 and the D90 were determined to be 77.729 µm, 261.149 µm and 517.698 µm, respectively.