Sodium ascorbate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-11-23 to 2010-03-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. Particle Size Distribution, Fibre Length and Diameter Distribution Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 Laser scattering / diffraction.

Deviations:

no

Principles of method if other than guideline:

Not further specified.

GLP compliance:

yes (incl. QA statement)

Type of method:

determination of fibre length and diameter distributions

Type of particle tested:

primary particle

Specific details on test material used for the study:

- Batch Number: TL00910581

Percentile:

D50

Mean:

< 45.5 µm

St. dev.:

3.045

Remarks on result:

other: The MMD of the test item indicates that 50% (by mass) of the particles are smaller than 45.5 µm

Percentile:

other: D5

Mean:

< 5.9 µm

St. dev.:

1.248

Percentile:

D10

Mean:

< 14.5 µm

St. dev.:

1.663

Percentile:

D50

Mean:

< 45.5 µm

St. dev.:

3.045

Percentile:

D90

Mean:

< 87.5 µm

St. dev.:

8.462

The test item is a white powder. Under the microscope (with a magnification of 100), rectangular platelets in different sizes were observed.

 

A solubility test showed, that the test item is both: sparingly soluble and well dispersible in
2-propanol. The particle size distribution of Sodium ascorbate crystalline was performed with three samples of the stock dispersion each measured in duplicate.

 

The individual measurements and the results obtained using the laser diffraction method of Sodium ascorbate crystalline are summarized in Table 1 and Table 2 (see below). The tables represent rounded results obtained by using the exact measurement data. An example of the particle size distribution curve is shown in Figure1(see attachements).

 

The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

Table1: Particle Size Distribution of the test item

	1^stRun Particle Size	2^ndRun Particle Size	3^rdRun Particle Size	4^thRun Particle Size	5^thRun Particle Size	6^thRun Particle Size	Mean Particle Size	Stand. Dev. ±
[%]	[µm]	[µm]	[µm]	[µm]	[µm]	[µm]	[µm]	[µm]
5	< 6.12	< 4.50	< 6.66	< 4.53	< 7.71	< 5.66	< 5.9	1.248
10	< 14.67	< 12.31	< 15.68	< 12.92	< 16.76	< 14.51	< 14.5	1.663
50	< 49.95	< 46.16	< 47.29	< 42.19	< 45.21	< 42.05	< 45.5*	3.045
90	< 97.57	< 97.44	< 87.96	< 82.36	< 82.50	< 77.20	< 87.5	8.462

 

*) TheMMDof the test item indicates that 50% (by mass) of the particles are smaller than 45.5 µm.

 

 

Table 2: Particle Size Distribution of the test item in [%] at the relevant Particle Size

[µm]	1^stRun	2^ndRun	3^rdRun	4^thRun	5^thRun	6^thRun	Mean	Stand. Dev.
	[%]	[%]	[%]	[%]	[%]	[%]	[%]	[%]
< 0.3	*****	*****	*****	*****	*****	*****
< 0.5	0.40	0.40	0.40	0.50	0.40	0.40	0.42	0.04
< 1.0	1.60	1.80	1.70	1.80	1.50	1.70	1.68	0.12
< 2.0	3.30	3.70	3.30	3.80	3.10	3.50	3.45	0.27
< 3.0	3.80	4.40	3.80	4.40	3.60	4.00	4.00	0.33
< 4.0	4.20	4.80	4.10	4.80	3.90	4.40	4.37	0.37
< 5.0	4.50	5.20	4.40	5.20	4.10	4.70	4.68	0.44
< 6.0	4.90	5.80	4.70	5.70	4.40	5.10	5.10	0.55
< 7.0	5.40	6.30	5.10	6.20	4.80	5.60	5.57	0.60
< 8.0	5.90	7.00	5.60	6.70	5.10	6.00	6.05	0.70
< 9.0	6.40	7.60	6.00	7.30	5.50	6.50	6.55	0.79
< 10.0	6.90	8.30	6.50	7.90	5.90	7.00	7.08	0.89
< 20.0	15.00	17.80	13.90	17.30	13.10	15.50	15.43	1.85
< 30.0	27.50	31.40	26.60	31.90	26.50	30.10	29.00	2.43
< 40.0	39.90	43.90	40.50	46.90	42.10	46.70	43.33	3.02
< 50.0	50.10	53.30	53.40	60.20	56.90	62.10	56.00	4.57
< 60.0	59.30	61.50	65.20	71.70	69.80	74.90	67.07	6.08
< 70.0	68.50	69.70	75.80	81.30	80.50	84.80	76.77	6.61
< 80.0	77.50	78.00	84.70	88.80	88.60	91.80	84.90	5.98
< 90.0	85.30	85.50	91.20	93.90	94.00	96.10	91.00	4.61
< 100.0	91.40	91.50	95.60	97.20	97.30	98.60	95.27	3.11
< 125.0	98.90	98.90	100.00	100.00	100.00	100.00	99.63	0.57
< 150.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 175.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 200.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 225.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 250.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 275.0	100.00	100.00	100.00	100.00	100.00	100.00	100.00	0.00
< 300.0	*****	*****	*****	*****	*****	*****

 

 

Conclusions:

In conclusion, using the laser diffraction method to study the particle size of the test item ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 45.5 µm. The particle size distribution was found to range from approximately 0.3 µm to 150.0 µm.

Executive summary:

Using the laser diffraction method to study the particle size of the test item ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 45.5 µm. The particle size distribution was found to range from approximately 0.3 µm to 150.0 µm.

 

Description of key information

Using the laser diffraction method to study the particle size of the test item ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 45.5 µm. The particle size distribution was found to range from approximately 0.3 µm to 150.0 µm.

Additional information

Using the laser diffraction method to study the particle size of the test item ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 45.5 µm. The particle size distribution was found to range from approximately 0.3 µm to 150.0 µm.