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EC number: 808-234-2 | CAS number: 1211443-61-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Sep 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- 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
- Reference substance name:
- 2-chloro-7-cyclopentyl-N,N-dimethyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- Cas Number:
- 1211443-61-6
- Molecular formula:
- C14 H17 Cl N4 O
- IUPAC Name:
- 2-chloro-7-cyclopentyl-N,N-dimethyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- ca. 205.932 µm
- Geometric standard deviation:
- ca. 0.36
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- ca. 40.041 µm
- St. dev.:
- 0.452
- Key result
- Percentile:
- D50
- Mean:
- ca. 207.372 µm
- St. dev.:
- 0.839
- Key result
- Percentile:
- D90
- Mean:
- ca. 380.229 µm
- St. dev.:
- 2.189
Applicant's summary and conclusion
- Conclusions:
- During the method development phase of the analysis trials were conducted using the dry powder module (DPM) only. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:
Module : DPM
Dispersant : Air
Dispersion pressure : 0 barg
Refractive index (sample) : 0.000 n
Absorption : 0 AU
Analysis Model : General Purpose (Normal)
Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.
The results of the formal analysis are presented in Table 8:1. In addition, a graph of volume (%) versus Particle Diameter (μm), and full particle size distribution, is provided in Graph 8.A (Average of 5 runs). - Executive summary:
The results of the laser diffraction test conducted to determine the particle size of LEE011-B7 are summarised in Table 5:1. The analysis was conducted using the dry powder module (DPM).
Particle Size Analysis using dry powder module (DPM)
Average (μm)
Volume weighted mean
212.755
Median
205.932
Mode
244.460
MMAD (mass median aerodynamic diameter)
235.700
d10 - 10 % of material is <
40.041
d50 - 50 % of material is <
205.932
d90 - 90 % of material is <
380.654
volume of sample < 10.00μm
2.08%
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