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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:
19 - 24 April 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:
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:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: crystalline
Remarks:
crystalline powder
Details on test material:
Batch No: 11679700
Storage: at room temperature, protected from light
Specific details on test material used for the study:
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:
3.6 µm
St. dev.:
0.02
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D50
Mean:
13.8 µm
St. dev.:
0.1
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D90
Mean:
174.3 µm
St. dev.:
5.75
Remarks on result:
other: Average result calculated from the results of two test series

Any other information on results incl. tables

Visual Microscope Analysis

(1) under a microscope with 5x magnification agglomerates can be observed

(2) under a microscope with 20x magnification agglomerates can be observed

(3) under a microscope with 50x magnification, the test item consists of a mixture of cylindrical and spherical particles at lower particle sizes.

Particle Size Distribution

The test item shows a bimodal particle size distribution with two peaks at approx. 10 µm and 250 µm.

Test series 1:

 Percentile  Particle size (µm)  Standard deviation
 D10  3.6  0.03
 D50  13.9  0.22
 D90  180.0 3.54

Test series 2:

 Percentile  Particle size (µm)  Standard deviation
 D10  3.6  0.01
 D50  13.7  0.08
 D90  168.5 1.71

Applicant's summary and conclusion

Conclusions:
The test item Adenosine-5'-monophosphate (CAS 61-19-8) has a median particle size D50 = 13.8 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 Adenosine-5'-monophosphate (AMP) (CAS 61 -19 -8) has a median particle size D50= 13.8 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).