(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1995 - May 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was firstly examined, at 13x, by Scanning Electron Microscopy (Stereoscan Cambridge 360) with powder covered by gold sputtering.
A sample of the test substance was then sieved in a 90 µm sieve shaken with a rocking motion for 10 minutes.
The material passing the sieve (particle size < 90 µm) was dispersed in n-octane and examined with a Particle Size Analyzer (Shimadzu SA CP3).

GLP compliance:

yes

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Percentile:

D50

Remarks on result:

not measured/tested

No.:

#1

Size:

> 90 µm

Distribution:

77 %

No.:

#2

Size:

>= 40 - <= 50 µm

Distribution:

>= 19 - <= 20 %

No.:

#3

Size:

< 10 µm

Distribution:

>= 3 - <= 4 %

Powder mixed with large crystals: 0.3-1.2 mm.

Particle size distribution (% of the sample total weight) of the test substance was:

> 90 µm: 77 %

< 40-50 µm: 19-20%

< 10 µm: 3-4 %

Conclusions:

Powder mixed with large crystals: 0.3-1.2 mm.
Particle size distribution (% of the sample total weight) of the test substance was:
> 90 µm: 77 %
< 40-50 µm: 19-20%
< 10 µm: 3-4 %

Executive summary:

For the particle size distribution, the test substance was firstly examine by Scanning Electron Microscopy. Then, a sample was sieved (90 µm) and the material passing the sieve was examined with a Particle Size Analyzer.

The micrographs show the presence of a fine powder mixed with large crystals whose dimension lies in the range 0.3...1.2 mm.

The material passing the 90 µm sieve was 23% of the sample total weight; under the examination of the Particle Size Analyzer it showed a bimodal size distribution with a first maximum at 10 µm and a second maximum at 40 -50 µm, representing, respectively, 3 -4 and 19 -20 % of the sample total weight.

Description of key information

Key study: no guideline was followed. GLP study.

Additional information

Key study: No guideline was followed. GLP study. Particle size distribution (% of the sample total weight) of the test substance was: > 90 µm: 77 %, < 40-50 µm: 19-20% and < 10 µm: 3-4 %.