5-potassium hydrogen L-glutamate

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:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 / SPO/BF/24/b

Version / remarks:

CIPAC MT 187 / SPO/BF/24/b

Principles of method if other than guideline:

5.2.1. Apparatus
Apparatus used: Coulter LS 13 320 and common laboratory equipment.
5.2.2. Description of the Method
The particle size analysis test was performed in accordance to a test procedure no. SPO/BF/24/b (ed. 4) based in CIPAC MT 187 using Coulter LS 13 320 with ULM (Universal Liquid Model).
A representative sample of the test item is dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source, a laser. The light scattered by the particles at various angles is measured by a multi-element detector and numerical, values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure, to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Test material

Test material information

1

Reference substance name:

5-potassium hydrogen L-glutamate

EC Number:

243-094-0

EC Name:

5-potassium hydrogen L-glutamate

Cas Number:

19473-49-5

Molecular formula:

C5H9NO4.K

IUPAC Name:

potassium 5-oxido-5-oxo-L-norvaline

Test material form:

solid

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

ca. 208.9 µm

St. dev.:

6.78

Particle size 2

Key result

Percentile:

D50

Mean:

ca. 427.5 µm

St. dev.:

4.57

Particle size 3

Key result

Percentile:

D90

Mean:

ca. 701.5 µm

St. dev.:

7.24

Any other information on results incl. tables

Table no. 4. Results of particle size distribution

Particles size	Test number and fraction size[µm]
	1	2	3	4	5	Avg.	Standard deviation, [µm]	Relative Standard Deviation, [%]
d10[µm]	217.8	213.4	208.1	204.1	201.1	208.9	6.78	3.25%
d50[µm]	433.2	430.9	427.2	423.6	422.6	427.5	4.57	1.07%
d90[µm]	712.2	704.3	700.5	693.2	697.3	701.5	7.24	1.03%
* d4,3, [µm]	449.8	444.4	440.0	434.8	434.9	440.8	6.43	1.46%

* Average d₄₃, [µm] – The mass moment mean (De Brouckere Mean Diameter)

Applicant's summary and conclusion

Conclusions:

The results of the particle size distribution test

d10 [µm] 208.9 µm
d50 [µm] 427.5 µm
d90 [µm] 701.5 µm

Executive summary:

Description of the Method

           The particle size analysis test was performed in accordance to a test procedure no.SPO/BF/24/b (ed. 4) based in CIPAC MT 187 using CoulterLS 13 320 with ULM (Universal Liquid Model).

A representative sample of the test item is dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source, a laser. The light scattered by the particles at various angles is measured by a multi-element detector and numerical, values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure, to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution.

Particle size distribution

CIPAC MT 187 / SPO/BF/24/b

Average d10= 208.9 µm, SD = 6.78 µm, RSD 3.25% Average d50= 427.5 µm, SD = 4.57 µm, RSD 1.07% Average d90= 701.5 µm, SD = 7.24 µm, RSD 1.03% Average d4,3= 440.8 µm, SD = 6.43 µm, RSD 1.46%