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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Qualifier:
according to
Guideline:
other: CIPAC MT 187
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Monitoring Authority, MHRA.
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: single crystalline particles with some agglomerations

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Ethyl Ascorbic acid
Physical state: White to very pale yellow crystalline powder
Test item storage: In freezer (≤ -15°C) desiccated
Stability: 21 April 2018 (retest date)

Results and discussion

Mass median aerodynamic diameter:
123.223 µm
Particle sizeopen allclose all
Percentile:
D10
Mean:
39.952 µm
St. dev.:
0.226
Remarks on result:
other: The standard deviation quoted is the standard deviation of the population.
Percentile:
D50
Mean:
101.633 µm
St. dev.:
0.271
Remarks on result:
other: The standard deviation quoted is the standard deviation of the population.
Percentile:
D90
Mean:
240.153 µm
St. dev.:
3.492
Remarks on result:
other: The standard deviation quoted is the standard deviation of the population.

Any other information on results incl. tables

Results

Table 1: Average values from 5 individual runs

 

**Average (of 5 runs)

Volume weighted Mean

123.570

Median (d.50)

101.633

Mode (μm)

100.593

*MMAD

123.223

10 % of material is <

39.952

50 % of material is <

101.633

90 % of material is <

240.153

 

All results are in μm

* Mass Median Aerodynamic Diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

3.11 % by volume of sample was seen to be < 10.00 μm.

 

Table 2: Standard Deviation results from 5 individual runs

Run No.

STDVP

% STDVP

d10

0.226

0.6

d50

0.271

0.3

d90

3.492

1.5

d15.78

0.287

0.6

GSD

0.009

0.5

MMAD

0.33

0.3

 

GSD = Geometric standard deviation

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Applicant's summary and conclusion