Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th September 2017 - 17th October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Mass median aerodynamic diameter:
149.794 µm
Key result
Percentile:
D10
Mean:
65.624 µm
St. dev.:
0.291
Key result
Percentile:
D50
Mean:
149.794 µm
St. dev.:
0.423
Key result
Percentile:
D90
Mean:
265.262 µm
St. dev.:
0.381

During the method development phase of the analysis trials were conducted using the dry powder module (DPM). The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:

Module : DPM

Dispersant : Air

Dispersion pressure : 0.0 barg

Refractive index (sample) : 1.500 n

Absorption : 0 AU

Analysis Model : General Purpose (Normal)

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm. The full results are presented below in Table 1.

Table 1: Full Test Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

Average*

Volume weighted mean

157.814

158.141

157.691

158.120

158.674

158.088

Median

149.338

149.875

149.398

149.843

150.515

149.794

Mode

167.940

168.439

167.805

168.541

168.937

168.334

d10 - 10 % of material is <

65.303

65.692

65.556

65.442

66.150

65.624

d50 - 50 % of material is <

149.338

149.875

149.398

149.843

150.515

149.794

d90 - 90 % of material is <

265.363

265.250

264.557

265.435

265.696

265.262

All results are in μm

* Average result is calculated from the entirety of data captured in each run and is not a simple

arithmetic mean

 

The coefficient of variation was determined to be <3% for d50 and <5% for d10 and d90. The repeatability of the results were therefore considered acceptable and within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
The particle size distribution for dilithium tetraborate was determined. The values obtained for d10, d50 and d90 were 65.624, 149.794 and 265.262 μm respectively (a mean of 5 runs).
Executive summary:

The test was conducted according to ISO 13320:2009 and CIPAC MT 187 to determine the particle size distribution of dilithium tetraborate.

The values obtained for d10, d50 and d90 were 65.624, 149.794 and 265.262 μm respectively (a mean of 5 runs).

The coefficient of variation determined for d50 was less than 3% and for d10 and d90 were less than 5%. The repeatability of the particles size distribution were therefore within the acceptable limits as per the ISO 13320-1 test standard.

Description of key information

The particle size distribution for dilithium tetraborate was determined.  The values obtained for d10, d50 and d90 were 65.624, 149.794 and 265.262 μm respectively (a mean of 5 runs).

Additional information