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Physical & Chemical properties

Particle size distribution (Granulometry)

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particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-03 to 2009-10-08
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
other: BS ISO 13320-1:1999
Principles of method if other than guideline:
Laser diffraction particle size analyzer / small volume dispersion in silicone oil
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
- Name of test material (as cited in study report): LL Lactide
- Batch no: 0902000694
- Purity 100 %
- Expiration date of the lot/batch: 2010-02-10
- Stability under storage conditions: stable
- test substance storage: at room temperature in the dark
- sample density: 1.33 g/cm³
Mass median aerodynamic diameter:
ca. 308 µm
Geometric standard deviation:
>= 2.82 - <= 2.92
66 µm
St. dev.:
Key result
267 µm
St. dev.:
1 426 µm
St. dev.:

Average (µm)

Volume weighted mean: 578.7 µm

Median (D50): 267.0 µm

Mode: 1206 µm

MMAD (Mass Median Aerodynamic Diameter): 308.0 µm

10 % of material is 66.4 µm

50 % of material is 267.0 µm

90 % of material is 1426 µm

1.87 % by volume of sample was seen to be <10 µm

In conclusion, it can be stated that a manual sieve analysis indicated that 99.1 % by weight of the sample had a particle size of <2000 µm. A subsequent laser diffraction analysis on the <2000 µm sample revealed that the median (d50) was 267 µm.
Executive summary:

In summary, the laser diffraction test conducted to determine the Particle size analysis produced the following results: Manual sieve analysis indicated that 99.1% by weight of the sampe had a particle size of <2000 µm. A subsequent laser diffraction analysis on the <2000 µm sample revealed that the median size (d50) was 267 µm and that the mass median aerodynamic diameter (MMAD) was 308 µm.

Description of key information

The MMAD of LL-lactide was determined to be 308 µm.

Additional information