Reaction mass of (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide and (2S)-2-[(4S)-2-oxo-4-propylpyrrolidin-1-yl]butanamide

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:

12 September 2006 - 6 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 method:

sieving

Type of particle tested:

primary particle

Type of distribution:

other: gravimetric

Key result

Percentile:

D50

Mean:

> 100 µm

Remarks on result:

other: see remark

Remarks:

The mass of test material passing through a 100 μm sieve was measured (1.88%).

Conclusions:

By using the sieve method, the proportion of test material having an inhalable particle size less than 100 μm was found to be 1.88%. The results indicate that the test substance has a a particle size that is essentially non-inhalable.

Description of key information

By using the sieve method, the proportion of test material having an inhalable particle size less than 100 μm was found to be 1.88%. The results indicate that the test substance has a a particle size that is essentially non-inhalable.