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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 September 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
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:
3-(aminocarbonyl)-1-ß-D-ribofuranosyl-pyridinium bromide
Cas Number:
78687-39-5
Molecular formula:
C11H15BrN2O5
IUPAC Name:
3-(aminocarbonyl)-1-ß-D-ribofuranosyl-pyridinium bromide
impurity 1
Chemical structure
Reference substance name:
Nicotinamide
EC Number:
202-713-4
EC Name:
Nicotinamide
Cas Number:
98-92-0
Molecular formula:
C6H6N2O
IUPAC Name:
nicotinamide
impurity 2
Chemical structure
Reference substance name:
Methanol
EC Number:
200-659-6
EC Name:
Methanol
Cas Number:
67-56-1
Molecular formula:
CH4O
IUPAC Name:
methanol
impurity 3
Chemical structure
Reference substance name:
Ethyl acetate
EC Number:
205-500-4
EC Name:
Ethyl acetate
Cas Number:
141-78-6
Molecular formula:
C4H8O2
IUPAC Name:
ethyl acetate
impurity 4
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Oxidane
impurity 5
Reference substance name:
inorganic salts by sulphated ash
IUPAC Name:
inorganic salts by sulphated ash
impurity 6
Chemical structure
Reference substance name:
Bromic acid
EC Number:
232-158-3
EC Name:
Bromic acid
Cas Number:
7789-31-3
Molecular formula:
BrHO3
IUPAC Name:
bromic acid
impurity 7
Reference substance name:
Unknown impurities.
Molecular formula:
Not available as unknown impurities.
IUPAC Name:
Unknown impurities.
Test material form:
solid
Details on test material:
Batch / Lot No. 1000146/01
Specific details on test material used for the study:
Batch No.: 1000146/01
Storage Conditions: Freezer (approx. -15 °C)
Since the test item contains no lager particles, sieving < 2000 µm was not necessary and the test item was used as delivered.

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
1.2 µm
St. dev.:
0.01
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D50
Mean:
4.8 µm
St. dev.:
0.03
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D90
Mean:
22.7 µm
St. dev.:
1.53
Remarks on result:
other: Average result calculated from the results of two test series

Any other information on results incl. tables

LIGHT MICROSCOPY

At 5x and 20x magnifications small agglomerates can be observed, which can be easily destroyed by mechanical force.

PARTICLE SIZE DISTRIBUTION

Two test series of 3 measurements each were performed with the test item.

Test series 1:

 Percentile  Particle size (µm)  Standard deviation
 D10  1.2 0.02
 D50  4.8 0.04
 D90  24.7 3.12

Test series 2:

Percentile  Particle size (µm)  Standard deviation
 D10  1.2 0.01
 D50  4.7 0.07
 D90  20.7 2.28

Applicant's summary and conclusion

Conclusions:
The test item Nicotinamide-beta-D-riboside bromide (CAS no. 78687-39-5) has a median particle size D50 = 4.8 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline OPPTS 830.7520 (1996).
Executive summary:

The test item Nicotinamide-beta-D-riboside bromide (CAS no.78687-39-5) has a median particle size of D50 = 4.8 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline 830.7520 (1996).