2-{3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl}ethyl hydrogen phosphate

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:

10 Aug - 16 Aug 2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Overall median particle size is an average of result from sieving analysis and of result from laser diffraction/scattering method.

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

adopted in 2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: DIN ISO 3310-1: Analytical Sieves

Deviations:

no

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: opaque partciles of irregular shapes, tending to agglomerate

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

Storage conditions: Ambient temperature (10 to 30 °C)

Percentile:

D10

Mean:

192.4 µm

St. dev.:

19.94

Remarks on result:

other: Individual test results: 178.3 µm, 206.5 µm

Percentile:

D50

Mean:

580.9 µm

St. dev.:

37.97

Remarks on result:

other: Individual test results: 554.1 µm, 607.8 µm

Percentile:

D90

Mean:

1 236 µm

St. dev.:

53.03

Remarks on result:

other: Individual results: 1199 µm, 1274 µm

Percentile:

D50

Mean:

2 200 µm

Remarks on result:

other: Median particle size of test item deduced from sieve analysis of the fraction sieved to > 1000 µm (49 wt. %).

Results
Laser diffraction
Median values were calculated from unrounded values.

The median particle size L₅₀(D (v, 0.5): 50% of particle volume or particle mass with lower particle diameter) deduced from these distributions were:
1^st test series L₅₀= 554.1 µm; 2^nd test series L₅₀= 607.8 µm
The average of the median particle size: L₅₀= 580.9 µm

The particle size L₁₀(D (v, 0.1): 105 of particle volume or particle mass with lower particle diameter) deduced from these distributions were:
1^st test series: L₁₀= 178.3 µm; 2^nd test series: L₁₀= 206.5 µm
The average of the particle size: L₁₀= 192.4 µm

The particle size L₉₀(D (v, 0.9): 90% of particle volume or particle mass with lower particle diameter) deduced from these distributions were:
1^st test series: L₉₀= 1199 µm; 2^nd test series: L₉₀= 1274 µm
The average of the particle size: L₉₀= 1236 µm

Sieving
Table 1 – Sieving analysis results

Mesh Size [µm]	Range of particle size [µm]	Fraction [g]	Total [g]	Fraction [%]	Total [%]
6300	>6300	11.46	11.46	7.68	7.68
4000	4000 – 6300	19.22	30.68	12.88	20.56
3150	3150 – 4000	12.70	43.38	8.51	29.08
2500	2500 – 3150	19.93	63.31	13.36	42.43
2000	2000 – 2500	19.50	82.81	13.07	55.50
1700	1700 – 2000	15.99	98.80	10.72	66.22
1400	1400 – 1700	19.98	118.78	13.39	79.61
1250	1250 – 1400	11.33	130.11	7.59	87.21
1000	0 – 1250	18.87	148.98	12.65	99.85

 

The missing amount to 100% (< 0.2%) could have been lost during handling of the open sieves and can be considered negligible. The median particle size was ca. 2200 µm.

Discussion
Since both methods used are based on different models, the results could not be combined to obtain overall values. This was consolidated by the fact that the laser diffraction showed particles > 1000 µm even when the test item was sieved to < 1000 µm prior to the test. Therefore, the mean value for both sieved fractions will be given as a final result.

Conclusion
The fractions were both nearly 50 wt. %, thus the overall median particle size of the test item can be evaluated as being approximately equal to 1000 µm.

The median test item particle size deduced from the laser diffraction of the fraction sieved to < 1000 µm (51 wt. %) was 581 µm.

The median test item particle size deduced from the sieve analysis of the fraction sieved to > 1000 µm (49 wt. %) was approximately 2200 µm.

Description of key information

Laser Diffraction Results (51 wt. %): D10 = 192.4 µm; D50 = 580.9 µm; D90 = 1236 µm
Median particle size: 581 µm

Sieving Analysis (49 wt %) - median particle size: 2200 µm

Overall median particle size: 1000 µm

(OECD 110, Laser Diffraction/Scattering)