(6R,7R)-7-[[(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-[(triphenylmethoxy)imino]acetyl]amino]-3-[(E)-[(3'R)-1'-[(1,1-dimethylethoxy)carbonyl]-2-oxo-[1,3'-bipyrrolidin]-3-ylidene]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid diphenylmethyl ester

Particle size distribution (Granulometry)

Description of key information

Particle Size Analysis using small volume (wet) module (SVM)	Average (μm)
Median (d.50)	10.3
Mode	9.71
10% of material is <	3.94
50% of material is <	10.3
90% of material is <	31.1
By volume of sample was seen to be < 10.00 μm	48.48%

 

Additional information

To characterise the particle size distribution of the powder. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser. The benefit of this procedure is that it allows the operator to obtain a better understanding of the particle characterisation of the material.

 

The test is conducted to determine the particle size distribution of BAL0001026. The sample is initially observed to determine whether sieving of the material is required. A method development for the particle size analysis on the material is then undertaken to obtain the correct parameters for the formal analysis. The method development is employed to identify the most appropriate optical properties for the material, the correct dispersant, dispersion pressures and sample compatibility. Once these parameters are obtained the final sample is then analysed using the Malvern Mastersizer 3000 Laser Diffraction Analyser. It is normal practice to complete 5 runs to ensure repeatability of results. The test is conducted in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.