(6R,7R)-7-[((2Z)-2-[({2-[(1,1-dimethylethyl)oxy]-1,1-dimethyl-2-oxoethyl}oxy)imino]-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetyl)amino]-8-oxo-3-(1-pyridiniumylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8-11 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

Version / remarks:

Took this guideline into consideration

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009 version

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Deviations:

no

GLP compliance:

yes

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

Sample was tested as received

Mass median aerodynamic diameter:

ca. 10.378 µm

Geometric standard deviation:

ca. 0.08

Remarks on result:

other: Average results are calculated from the entirety of the data and are not simple arithmetic means

Key result

Percentile:

D10

Mean:

ca. 2.47 µm

St. dev.:

0.04

Key result

Percentile:

D50

Mean:

ca. 9.566 µm

St. dev.:

0.075

Key result

Percentile:

D90

Mean:

ca. 40.672 µm

St. dev.:

0.398

No.:

#1

Size:

< 10 µm

Distribution:

ca. 51.99 %

During the method development phase of the analysis trials were conducted using both the dry powder module (DPM) and the small volume (wet) module (SVM). The SVM trials were conducted using water as the dispersant. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were. Using the identified parameters, the particle size was analysed over the range 0.02 µm to 2000 µm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:

Average MMAD for the substance as supplied was determined at 10.378 μm, with a standard deviation of 0.08 μm using a laser diffraction method.
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Executive summary:

The Mass Median Aerodynamic Diametre of a sample of the substance was determined by Laser Diffraction Particle Analysis at 10.378μm with a standard deviation of 0.08 μm (0.8%). Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.

Description of key information

Average MMAD for the substance as supplied was determined at 10.378 μm, with a standard deviation of 0.08 μm using a laser diffraction method.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.