L-Ascorbic acid, 3-O-ethyl-

Particle size distribution (Granulometry)

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 13320:2009

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

GLP compliance:

yes (incl. QA statement)

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

Test material information

Constituent 1

Reference substance name:

(5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one

EC Number:

617-849-3

Cas Number:

86404-04-8

Molecular formula:

C8H12O6

IUPAC Name:

(5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one

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 size

Particle size 1

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.

Particle size 2

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.

Particle size 3

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