Toluene-4-sulphonic acid

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:

August 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Guideline:

other: Quality manual P17 - AKP 533. Light scattering

Principles of method if other than guideline:

Quality manual P17 - AKP 533. Light scattering

Instrument:
Horiba Partica LA-950 (measurement range from 10 nm to 3000 μm)

Conditions of measurement:
Fraction cell
Refractive index of sample: 1.600 – 0.000i
Refractive index of dispersant: 1.460 (paraffinum perliquidum)
Transmittance (R): 96 – 80%
Transmittance (B): 98 – 84%

Sample preparation:
A small amount of the sample was inserted in the 25 ml beaker; approximately 10 ml of paraffinum perliquidum was added and dispersed for 1 minute in the ultrasonic tank. Particle size distribution was measured at conditions described above. The whole measuring procedure was repeated for five times. Average value was computed from the resulting values. The value nearest to average was used as final result of the test.

GLP compliance:

no

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Percentile:

D50

Mean:

ca. 346.7 µm

Remarks on result:

not measured/tested

Remarks:

Std Dev not reported

Percentile:

D10

Mean:

ca. 163 µm

Remarks on result:

not measured/tested

Remarks:

Std Dev not reported

Percentile:

D90

Mean:

ca. 660.8 µm

Remarks on result:

not measured/tested

Remarks:

Std Dev not reported

Results:

For indication of the particle size statistical value was used:

Median Size - is the value, which divides the population exactly two equal halves (i.e. there is 50% of the distribution above this value and 50% below).

Diameter on Cumulative 10%: 10% of particle is less then this value

Diameter on Cumulative 90%: 90% of particle is less then this value

Span

Diameter on cumulative 90% – Diameter on cumulative 10%

Span = --------------------------------------------------------------------------------

Median

Extended uncertainty of determination of the median is 10 %.

Extended uncertainty was calculated by using coefficient 2 (for normal distribution agrees with probability of coverage about 95%).

Conclusions:

Mass median diameter: 346.7 um

Description of key information

Mass median diameter: 346.7 um