4-methyl-salicylamide

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:

other: According to official guidelines and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: CTL SOP No. 417

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO 13320:2009

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

Principles of method if other than guideline:

To characterise the particle size distribution of the powder. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser. The benefit of this procedure is that it allows the operator to obtain a better understanding of the particle characterisation of the material. This includes, but is not limited to, sample clusters and agglomerations which may provide false values in the formal particle size analysis. In these situations, where the operator can assess how easily these clusters or agglomerations are dispersed, ultrasonics may be employed. Owing to the extremely small quantities of material used in this analysis it should be noted that discrepancies can arise between the lower and upper limits of the particle size and the actual value obtained in the formal particle size analysis.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

solid: crystalline

Details on test material:

Identification: V250208
Appearance: Off-white crystals
Batch: F8A
Purity/Composition: >96 %
<3 % 4-methylsalicylacid
<1 % 4-methylsalicylacid-methylester
<0.5 % water
Test item storage: At room temperature protected from light
Stable under storage conditions until: 03 September 2016 (expiry date)
Molecular formula: C8H9NO2
Molecular weight: 151.16

Results and discussion

Mass median aerodynamic diameter:

>= 156.7 - <= 165.24 µm

Geometric standard deviation:

>= 10.709 - <= 11.136

Particle size

Particle size 1

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Percentile:

D10

Mean:

7.279 µm

St. dev.:

0.061

Particle size 3

Percentile:

D50

Mean:

136.751 µm

St. dev.:

3.079

Particle size 4

Percentile:

D90

Mean:

442.54 µm

St. dev.:

6.772

Any other information on results incl. tables

13.15 % by volume of sample was seen to be<10.00 μm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.