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EC number: 248-953-3 | CAS number: 28305-25-1
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Specific details on test material used for the study:
- - Name of test material: PURACAL PP/USP (Calcium-L-Lactate 5-Hydrate Powder USP)
- Physical state: solid
- Analytical purity: 73-95%
- Lot/batch No.: 1107003133
- Expiration date of the lot/batch: 2016-07-29
- Storage condition of test material: 15-30 °C - Geometric standard deviation:
- 0.01
- Key result
- Percentile:
- D50
- Mean:
- 217 µm
- Remarks on result:
- other: St. dev. not available
- Percentile:
- other: Volume weighted mean
- Mean:
- 235 µm
- St. dev.:
- 0.93
- Conclusions:
- A particle size analysis of the test material showed that the median size (d50, mode) was 217 µm.
- Executive summary:
A particle size analysis of Puracal PP/USP was performed in accordance with the guidelines ISO 13320:2009 and CIPAC MT 187 under GLP requirements.
The laser diffraction test was conducted to determine the particle size analysis produced the following results:Particle Size Analysis using dry powder module (DPM)
Average (µm)
Volume weighted mean
235.386
Median (d.50) Mode
216.995
10 % of material is <
223.960
50 % of material is <
115.989
90 % of material is <
385.146
by volume of sample was seen to be < 10.00 µm
0.0%
Reference
The table below represents a summary of the results:
Particle Size Analysis using dry powder module (DPM) |
Average (µm) |
Volume weighted mean |
235.386 |
Median (d.50) Mode |
216.995 |
10 % of material is < |
223.960 |
50 % of material is < |
115.989 |
90 % of material is < |
385.146 |
by volume of sample was seen to be < 10.00 µm |
0.0%
|
Description of key information
A particle size analysis of Puracal PP/USP
was performed in accordance with the guidelines ISO 13320:2009 and CIPAC
MT 187 under GLP requirements.
The test material showed a median size of 217 µm (d50).
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