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EC number: 812-520-2 | CAS number: 1259279-57-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- ISO 13320:2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Chilworth Technology Ltd SOP n°417
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- 5-fluoro-1-(4-methylbenzenesulfonyl)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-pyrrolo[2,3-b]pyridine
- EC Number:
- 812-520-2
- Cas Number:
- 1259279-57-6
- Molecular formula:
- C20H22BFN2O4S
- IUPAC Name:
- 5-fluoro-1-(4-methylbenzenesulfonyl)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-pyrrolo[2,3-b]pyridine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-63757044-AAA (T003686)
- Physical state: solid (powder)
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- - Batch n°: I16HD3479
- Expiration date: 03 September 2018 (retest date)
- Purity: 100.0% (based on HPLC)
- Storage condition of test material: At room temperature
Results and discussion
- Mass median aerodynamic diameter:
- 212 µm
- Geometric standard deviation:
- >= 1.43 - <= 1.439
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- 111 µm
- St. dev.:
- 0.409
- Remarks on result:
- other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
- Key result
- Percentile:
- D50
- Mean:
- 183 µm
- St. dev.:
- 0.611
- Remarks on result:
- other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
- Percentile:
- D90
- Mean:
- 289 µm
- St. dev.:
- 1.6
- Remarks on result:
- other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Any other information on results incl. tables
Visual Microscope Analysis
(1) Standard visual observation: sample observed to be a coarse to medium size, gritty, free flowing white powder with clusters.
(2) 3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 16 µm and largest +/- 176 µm).
(3) 40 objective lens: sample was observed to be made up of single crystalline particles.
Solubility and Dispersability Test
The sample proved to be insoluble and well dispersed in silicone oil. Therefore, silicone oil was used as the disperant.
Laser Diffraction Particle Size Analysis
Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm.
The average Volume weighted Mean was 192 µm and the mode was 191 µm. The Coefficient of Variation for d50 was <3%; d10 and d90 were <5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.
Applicant's summary and conclusion
- Conclusions:
- Observation using 3.2 objective lens showed irregular shaped crystals between approximately 16 µm and 176 µm.
The particle size distribution of T003686 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 192 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 212 µm, whereas the average D10, D50 and the D90 were determined to be 111 µm, 183 µm and 289 µm, respectively.
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