Registration Dossier
Registration Dossier
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EC number: 266-104-5 | CAS number: 66069-34-9
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
Description of key information
The particle size distribution study conducted by C Simmons which has been conducted at Chilworth Research facility has shown that the results are repeatable and representative and within acceptable limits. The Mass Median Aerodynamic Diameter has been shown to be 32.724µm and 6.90% of the substance was seen to be < 10.00 μm.
Additional information
The test was conducted to determine the particle size distribution of tBA Clavulanate. The sample was analysed using a Malvern Mastersizer 2000 laser Diffraction Analyser.
The particle size was analysed over the range 0.02 μm to 2000 μm. In addition, a graph of volume (%) versus Particle Diameter (μm), and full particle size distribution, has been conducted and is included within the robust study summary.
The standard deviation has shown that the results are repeatable and representative and within accetable limits. The Mass Median Aerodynamic Diameter has been shown to be 32.724µm and 6.90% of the substance was seen to be < 10.00 μm.
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