Methyl 3-aminopyrazinecarboxylate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 March, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Principles of method if other than guideline:

OECD 110 was taken into consideration.

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:

Methyl 3-aminopyrazinecarboxylate

EC Number:

240-387-5

EC Name:

Methyl 3-aminopyrazinecarboxylate

Cas Number:

16298-03-6

Molecular formula:

C6H7N3O2

IUPAC Name:

methyl 3-aminopyrazine-2-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Amiloride Compound 6
- Description: Tan powder
- Storage condition of test material: In refrigerator (2-8°C) protected from light, desiccated
- Other: Reactive to light, moisture and oxygen

Results and discussion

Mass median aerodynamic diameter:

>= 339.976 - <= 362.475 µm

Geometric standard deviation:

>= 2.552 - <= 2.743

Particle size

Particle size 1

Percentile:

D10

Mean:

68.139 µm

St. dev.:

2.23

Particle size 2

Percentile:

D50

Mean:

293.735 µm

St. dev.:

7.02

Particle size 3

Percentile:

D90

Mean:

571.344 µm

St. dev.:

11.16

Particle size distribution at different passages

No.:

#1

Size:

< 10 µm

Distribution:

ca. 4.97 %

Any other information on results incl. tables

MMAD mean: 350.026 µm

Volume weighted mean: 309.375 µm

Mode: 384.819 µm

 

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:

The particle size distribution of the substance was determined by laser diffraction analysis-'wet' small volume dispersion method (in accordance with ISO 13320 and CIPAC MT 187 and in compliance with GLP); MMAD= 350 µm; 5% is < 10 µm; 10% is < 68 µm; 50% is < 294 µm and 90% is < 571 µm.