Methyl 4-[4-(4-methoxybenzoylamino)-3-nitrophenyl]-3-methyl-4-oxo-butyrate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 August 2008 to 30 January 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

counted distribution

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-290-2

EC Name:

-

Cas Number:

74149-72-7

Molecular formula:

C20H20N2O7

IUPAC Name:

methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): GAMMA NAP
- Substance type: monoconstituent
- Physical state: yellow powder
- Analytical purity: 99.9%
- Purity test date: 11 January 2008
- Lot/batch No.: 07/004/2
- Expiration date of the lot/batch: January 2009
- Storage condition of test material: in darkness at room temperature

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

143.872 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Percentile:

D90

Mean:

409.384 µm

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

<= 1 mm

Distribution:

0.07 %

Particle size distribution at different passages 2

No.:

#2

Size:

<= 100 µm

Distribution:

27.2 %

Particle size distribution at different passages 3

No.:

#3

Size:

<= 90 µm

Distribution:

18.7 %

Particle size distribution at different passages 4

No.:

#4

Size:

<= 63 µm

Distribution:

0.2 %

Applicant's summary and conclusion

Executive summary:

Preliminary sieving:

The majority of the particles was lower than 100 µm. So the principal sieving was made lower than 100 µm.

Principal sieving:

As the powder was fine and sticky, the particle size distribution was made by laser granulometry.

Particle size distribution by laser diffraction:

Median diameter: 143.872 µm

Mean diameter: 233.977 µm

D(0.9): 409.384 µm