Adenosine 5'-(trihydrogen diphosphate), monopotassium salt

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-30 until 2021-01-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 3

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

Test material information

Constituent 1

Reference substance name:

Adenosine 5'-(trihydrogen diphosphate), monopotassium salt

EC Number:

274-533-4

EC Name:

Adenosine 5'-(trihydrogen diphosphate), monopotassium salt

Cas Number:

70285-70-0

Molecular formula:

C10H14KN5O10P2

IUPAC Name:

potassium;[(2R,3S,4R,5R)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl hydrogen phosphate

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

impurity 2

Reference substance name:

Sum of impurities from ADP, K (each < 1 %)

IUPAC Name:

Sum of impurities from ADP, K (each < 1 %)

Test material form:

solid: particulate/powder

Details on test material:

Batch No.: 37779100
Storage Conditions: Refrigerator (approx. 2 °C to 8 °C)

Specific details on test material used for the study:

Batch No.: 37779100
Storage: Refrigerator (approx. 2 °C to 8 °C)

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

0.7 µm

St. dev.:

0.01

Remarks on result:

other: Average result calculated from the results of two test series

Particle size 2

Key result

Percentile:

D50

Mean:

4.3 µm

St. dev.:

0.37

Remarks on result:

other: Average result calculated from the results of two test series

Particle size 3

Key result

Percentile:

D90

Mean:

133.2 µm

St. dev.:

9.23

Remarks on result:

other: Average result calculated from the results of two test series

Any other information on results incl. tables

Light microscopy

The optically investigation of the test items were performed with different magnifications. For a better visualization a 10x10 grid with 100 µm squares was used. At 5x bigger particles or agglomerates can be observed. Examining the 20x magnification, the test item primarily consists of small crystalline particles.

Applicant's summary and conclusion

Conclusions:

The test item Adenosine 5'-diphosphate monopotassium salt (dried) (CAS no. 70285-70-0) has a median particle size of D50 = 4.3 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Test Guideline OPPTS 830.7520 (1996).

Executive summary:

The test item Adenosine 5'-diphosphate monopotassium salt (dried) (CAS no. 70285-70-0) has a median particle size of D₅₀ = 4.3 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Test Guideline OPPTS 830.7520 (1996).