Hydroxyl-2-pyridone

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-04-03 to 2018-04-05

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

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: Chilworth Technology Ltd SOP n°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:

Hydroxyl-2-pyridone

EC Number:

212-506-0

EC Name:

Hydroxyl-2-pyridone

Cas Number:

822-89-9

Molecular formula:

C5H5NO2

IUPAC Name:

1-hydroxy-1,2-dihydropyridin-2-one

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): Oxy PYRION
- Physical state: solid (powder)
- Appearance: white speckled gold powder

Specific details on test material used for the study:

- Batch n°: OXY-16-0806
- Analytical purity: >100%
- Expiration date: 16 July 2021
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:

429.348 µm

Geometric standard deviation:

>= 2.873 - <= 3.418

Particle size

Particle size 1

Percentile:

D10

Mean:

74.368 µm

St. dev.:

1.995

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:

356.677 µm

St. dev.:

6.662

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:

688.524 µm

St. dev.:

31.198

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 polydispersed, free flowing, white speckled gold powder

(2) 3.2 objective lens: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 10 μm and the largest individual size was approximately 1056 μm.

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

 

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in both silicone oil and sunflower oil. Both solvents were therefore trialled as the dispersant.

 

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

The average Volume weighted Mean was 374.585 µm and the mode was 447.139 µm. 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 a 3.2 objective lens showed irregular shaped crystals between approximately 10µm and 1056µm.
The particle size distribution of Hydroxypyridone determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 374.585 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 429.348 µm, whereas the average D10, D50 and the D90 were determined to be 74.368 µm, 356.677 µm and 688.524 µm, respectively.