1-[(E)-(2-Chlorophenyl)(methylimino)methyl]cyclopentanol

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 August - 16 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: CTL SOP No. 417

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:

1-[(2-chlorophenyl)(methylimino)methyl]cyclopentan-1-ol

EC Number:

641-894-8

Cas Number:

6740-87-0

Molecular formula:

C13H16ClNO

IUPAC Name:

1-[(2-chlorophenyl)(methylimino)methyl]cyclopentan-1-ol

Test material form:

solid

Specific details on test material used for the study:

- Lot/batch No.of test material: I17BB0589
- Expiration date of the lot/batch: 12 February 2018 (retest date)
- Analytical Purity: 99.50% (based on chromatographic purity)
- Storage condition of test material: In refrigerator (2-8°C) under argon

Results and discussion

Mass median aerodynamic diameter:

454.026 µm

Geometric standard deviation:

>= 2.24 - <= 2.37

Particle size

Particle size 1

Percentile:

D10

Mean:

115.053 µm

St. dev.:

2.672

Remarks on result:

other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Particle size 2

Key result

Percentile:

D50

Mean:

402.883 µm

St. dev.:

4.997

Remarks on result:

other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Particle size 3

Percentile:

D90

Mean:

762.875 µm

St. dev.:

10.705

Remarks on result:

other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a medium and coarse white powder.

(2)  3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 19 µm and largest +/- 960 µm).

(3) 40 objective lens: sample was observed to be made up of single crystalline particles.

 

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.2 μm to 2000 μm.

The average Volume weighted Mean was 426.456µm and the mode was 488.994µm. The Coefficient of Variation for d50 was <3%; d10 and d90 were <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 using 3.2 objective lens showed irregular shaped crystals between approximately 19 µm and 960 µm.
The particle size distribution of T003641 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 426.456 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 454.026 µm, whereas the average D10, D50 and the D90 were determined to be 2.672 µm, 4.997 µm and 10.705 µm, respectively.