1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 Aug 2020 to 05 Aug 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction, Handbook K.

Version / remarks:

2007

Deviations:

no

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-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

EC Number:

627-199-2

Cas Number:

120728-10-1

Molecular formula:

C10H17NO4

IUPAC Name:

1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

Test material form:

solid: particulate/powder

Details on test material:

Physical state: powder
Appearance: white powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch number of test material: AC07N1912008
- Expiry date: 02 January 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 98.9%
- Purity correction factor: not required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: not indicated
- Stability under test conditions: not applicable
- Solubility and stability of the test item in the solvent/vehicle: a dispersant was selected in which the test item's solubility was below 50 mg/L and in which it could be well and homogeneously dispersed.

Results and discussion

Mass median aerodynamic diameter:

42

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

11.8 µm

St. dev.:

0.027

Particle size 2

Key result

Percentile:

D50

Mean:

38.5 µm

St. dev.:

0.36

Particle size 3

Key result

Percentile:

D90

Mean:

85.5 µm

St. dev.:

0.599

Any other information on results incl. tables

In the preliminary test, the substance was concluded to be visually insoluble in the dispersant, thus only dispersability was investigated in the main test.

The test item proved to be homogeneously and well dispersed in Iso-G and therefore this solvent was used as the dispersant in the Laser Diffraction Analysis.

The particle size distribution of the test item was analysed over the range 0.01 μm to 1400 μm.

The coefficient of variation for D50 is less than 3%, and for D10 and D90 is less than 5%. It can be concluded that the repeatability of the measured particle size distributions is within the acceptable limits.

Applicant's summary and conclusion

Conclusions:

The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM).
The D50 of the test item was determined to be 38.5 μm, the D10 was 11.8 μm and the D90 was 85.5 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 42.0 μm.