Benzyltriphenylphosphonium chloride

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:

From October 3rd, 2017 to December 4th, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to 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

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

- Analytical purity: >=99.5%
- Purity test date: 02 March 2017
- Lot/batch No.: 180739
- Expiration date of the lot/batch: Not specified
- Appearance: Off-white powder
- Storage: At room temperature

Mass median aerodynamic diameter:

49.244 µm

Geometric standard deviation:

0.107

Percentile:

D10

Mean:

19.108 µm

St. dev.:

0.171

Percentile:

D50

Mean:

44.767 µm

St. dev.:

0.097

Percentile:

D90

Mean:

80.068 µm

St. dev.:

0.167

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 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 average d10, d50 and d90 were <19.108 µm, <44.767 µm and <80.068 µm, respectively. The coefficient of variation for d50 was less than 3%; those for d10 and d90 were less than 5%. Thus repeatability of the characteristic particles in the size distribution were within the acceptable limits as per the ISO 13320-1 test standard.

5.37 % by volume of sample was seen to be < 10.00 μm.

Conclusions:

The average MMAD of the test item was 49.244 µm. The average d10, d50 and d90 were <19.108 µm, <44.767 µm and <80.068 µm, respectively.

Executive summary:

The particle size distribution of the test item was determined in a GLP-compliant study performed in accordance with ISO 13320:2009, using the laser diffraction method. The average MMAD of the test item was 49.244 µm. The average d10, d50 and d90 were <19.108 µm, <44.767 µm and <80.068 µm, respectively.

Description of key information

The particle size distribution of the test item was determined in a GLP-compliant study performed in accordance with ISO 13320:2009, using the laser diffraction method. The average MMAD of the test item was 49.244 µm. The average d10, d50 and d90 were <19.108 µm, <44.767 µm and <80.068 µm, respectively.

Additional information

The particle size distribution of the test item was determined in one GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1)

and was selected as a key study for the endpoint.