α-hydroxy-β,β-dimethyl-γ-butyrolactone

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31.08.2009 - 04.11.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research md Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of distribution:

counted distribution

Test material

Test material information

Constituent 1

Reference substance name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

EC Number:

209-963-3

EC Name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

Cas Number:

599-04-2

Molecular formula:

C6H10O3

IUPAC Name:

(3R)-3-hydroxy-4,4-dimethyloxolan-2-one

Constituent 2

Reference substance name:

209 963 3

IUPAC Name:

209 963 3

Details on test material:

- Name of test material (as cited in study report): R-Pantolactone
- Physical state: solid
- Analytical purity: 99.6%
- Storage condition of test material: RT

Results and discussion

Particle size

Percentile:

D50

Mean:

2 000 - 4 000 µm

Remarks on result:

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

Any other information on results incl. tables

Mesh size (µm)  5000	Mean (%)  17.27
4000	48.53
2000	33.94
1000	0.12
500	0.05
250	0.03
125	0.07
75	0.00
<75	0.00

Applicant's summary and conclusion

Conclusions:

The main agglomerate size was found in the range of 4000 µm to 2000 µm.

Executive summary:

In the present study the sieving test with different sizes of sieves was performed. It can be stated that the particles of R-Pantolactone form agglomerates. The measurement of the single particles was not possible. There were only few fractions with a size below 250 pm in the sieve test. The main agglomerate size was found in the range of 4000 µm to 2000 µm.