tetraammine palladium (II) hydrogen carbonate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP. Limited reporting detail.

Qualifier:

according to guideline

Guideline:

other: Particle size distribution, fibre length and diameter distribution. June 1996 European Commission technical guidance document

Deviations:

not specified

Remarks:

Guideline not available for consultation and comparison. However, reporting detail is limited (e.g. missing information on purity)

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of distribution:

mass based distribution

Percentile:

D50

Remarks on result:

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

No.:

#1

Size:

< 45 µm

Distribution:

96 %

No.:

#2

Size:

< 10 µm

Distribution:

13.4 %

The results indicate that approximately 13.4% of the particles were of a size which could be expected to achieve alveolar deposition in man, if inhaled. Approximately 96% of the particles were sufficiently small to reach at least the tracheo-bronchial region of the respiratory tract [although it should be noted that the sample was sieved prior to analysis, removing most of the particles > 45 um].

Conclusions:

In a guideline study, conducted to GLP, the particle size distribution of tetraamminepalladium(II) hydrogen carbonate was determined by mass difference following cascade impaction. 13.4% of the pre-sieved (< 45 um) particles had a size < 10 um, and could be expected to achieve alveolar deposition in man, if inhaled. Approximately 96% of the pre-sieved particles were sufficiently small to reach at least the tracheo-bronchial region of the respiratory tract.

Executive summary:

In a guideline study, conducted to GLP, the particle size distribution of tetrammine palladium hydrogen carbonate was determined by mass difference following cascade impaction. 13.4% of the pre-sieved (< 45 um) particles had a size < 10 um, and could be expected to achieve alveolar deposition in man, if inhaled. Approximately 96% of the pre-sieved particles were sufficiently small (< 45 um) to reach at least the tracheo-bronchial region of the respiratory tract.

Reference 2

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 February 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only a 1 page study summary, though the critical information for this endpoint is included.

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Deviations:

not specified

GLP compliance:

yes

Other quality assurance:

other: no data

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: no data

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1212/14-A6
- Expiration date of the lot/batch: No data
- Purity test date: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data
- Final dilution of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid: No data

Percentile:

D10

Mean:

23 µm

Remarks on result:

other: average of three measurements

Percentile:

D50

Mean:

82 µm

Remarks on result:

other: average of three measurements

Percentile:

D90

Mean:

154 µm

Remarks on result:

other: average of three measurements

Conclusions:

In a particle size distribution study with tetraamminepalladium(II) hydrogen carbonate, respective d10, d50 and d90 values of 23, 82 and 154 μm were measured.

Executive summary:

In a guideline (ISO 13320) particle size distribution study with tetraamminepalladium(II) hydrogen carbonate, respective d10, d50 and d90 values of 23, 82 and 154 μm were measured using laser diffraction.

Description of key information

In a guideline study, conducted to GLP, the particle size distribution of tetraamminepalladium(II) hydrogen carbonate was determined by mass difference following cascade impaction. 13.4% of the pre-sieved (< 45 um) particles had a size < 10 um, and could be expected to achieve alveolar deposition in man, if inhaled. Approximately 96% of the pre-sieved particles were sufficiently small (< 45 um) to reach at least the tracheo-bronchial region of the respiratory tract (Mulle and Bartlett, 1997).

In a guideline (ISO 13320) particle size distribution study with tetraamminepalladium(II) hydrogen carbonate, respective d10, d50 and d90 values of 23, 82 and 154 μm were measured using laser diffraction.