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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 March 2017 - 28 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
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

Constituent 1
Chemical structure
Reference substance name:
(2S)-2-[(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-11,15-dimethoxy-13-oxa-3-azahexacyclo[13.2.2.1²,⁸.0¹,⁶.0⁶,¹⁴.0⁷,¹²]icosa-7,9,11-trien-16-yl]-3,3-dimethylbutan-2-ol
Cas Number:
16524-65-5
Molecular formula:
C30H43NO4
IUPAC Name:
(2S)-2-[(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-11,15-dimethoxy-13-oxa-3-azahexacyclo[13.2.2.1²,⁸.0¹,⁶.0⁶,¹⁴.0⁷,¹²]icosa-7,9,11-trien-16-yl]-3,3-dimethylbutan-2-ol
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-18163678-AAA (T002713)
- Physical state: solid (powder)
- Appearance: White powder
Specific details on test material used for the study:
- Batch n°: I16FB3164
- Expiration date of the lot/batch: 28 June 2017
- Analytical Purity: 100% (based on base titration assay)
- Storage condition of test material: At room temperature

Results and discussion

Mass median aerodynamic diameter:
223.48 µm
Geometric standard deviation:
>= 2.196 - <= 2.257
Particle sizeopen allclose all
Percentile:
D10
Mean:
71.756 µm
St. dev.:
0.856
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:
204.864 µm
St. dev.:
3.879
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:
440.974 µm
St. dev.:
11.653
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 medium size, white crystalline powder with clusters and agglomerations.

(2) 100x magnification: particles appeared to be irregular shaped crystals.(smallest +/- 10 µm and largest +/- 576 µm)

(3) 400x magnification: 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 suspension fluid.

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

The average Volume weighted Mean was 234.290 µm and the mode was 245.478 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:
Visual examination at 100x magnification showed irregular shaped crystals of approximately 10 µm and 576 µm. The larger particles appeared rectangular in shape whilst the smaller particles were of irregular shape.
The particle size distribution of T002713 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 234.290 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 223.480 µm, whereas the average D10, D50 and the D90 were determined to be 71.756 µm, 204.864 µm and 440.974 µm, respectively.