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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted under GLP and according to ISO 13320:2009

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009 and CIPAC MT 187
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of distribution:
other: laser diffraction

Test material

Constituent 1
Chemical structure
Reference substance name:
Adenosine 5'-(trihydrogen diphosphate), 2'-(dihydrogen phosphate), 5'→5'-ester with 3-(aminocarbonyl)-1-β-d-ribofuranosylpyridinium hydroxide, inner salt, disodium salt
EC Number:
246-129-8
EC Name:
Adenosine 5'-(trihydrogen diphosphate), 2'-(dihydrogen phosphate), 5'→5'-ester with 3-(aminocarbonyl)-1-β-d-ribofuranosylpyridinium hydroxide, inner salt, disodium salt
Cas Number:
24292-60-2
Molecular formula:
C21H28N7O17P3.2Na
IUPAC Name:
Adenosine 5'-(trihydrogen diphosphate), 2'-(dihydrogen phosphate), 5'→5'-ester with 3-(aminocarbonyl)-1-β-d-ribofuranosylpyridinium hydroxide, inner salt, disodium salt
Details on test material:
- Substance type: organic
- Physical state: white crystalline powder

Results and discussion

Mass median aerodynamic diameter:
33.01 µm
Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 5.698 µm
St. dev.:
0.085
Percentile:
D50
Mean:
ca. 25.621 µm
St. dev.:
0.551
Percentile:
D90
Mean:
ca. 300.601 µm
St. dev.:
5.905

Any other information on results incl. tables

Full Test Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

**Average

Volume weighted Mean

98.462

99.750

101.986

107.061

101.093

101.670

Median (d.50)

26.142

26.204

24.739

25.774

25.293

25.621

Mode (µm)

11.980

11.859

11.742

11.610

11.515

11.741

*MMAD

33.681

33.761

31.874

33.208

32.588

33.010

10 % of material is <

5.826

5.770

5.653

5.656

5.594

5.698

50 % of material is <

26.142

26.204

24.739

25.774

25.293

25.621

90 % of material is <

294.089

295.869

307.082

308.879

299.845

300.601

All results are in µm

* Mass Median Aerodynamic Diameter

** Average result is calculated from the entirety of data captured in each run and is not a

simple arithmetic mean.

23.99 % by volume of sample was seen to be < 10.00 µm.

Applicant's summary and conclusion

Conclusions:
Average (µm)
Volume weighted mean 101.670
Median (d.50) 25.621
Mode 11.741
MMAD (Mass Median Aerodynamic Diameter) 33.010
10 % of material is < 5.698
50 % of material is < 25.621
90 % of material is < 300.601
Executive summary:

Both visual microscope and laser diffraction test were conducted to determine the particle size analysis of NADP,diNa powder. The study was conducted in accordance with ISO 13320:2009. For the full solubility and dispersability test, silicone oil was selected. The sample proved to be insoluble and well dispersed in silicone oil, therefore it was chosen as the suspension fluid.

The particle size was analysed over the range 0.02 Um to 2000 Um. The Mass Median Aerodynamic Diameter (MMAD) was 33.010 Um.