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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 February 2018 to 17 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CIPAC MT 59
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: New Zealand Pharmaceuticals, 68 Weld Street, Palmerston North 4472, New Zealand (Batch No. 2216242)
- Expiration date of the lot/batch: 07 November 2021
- Purity: 91.2 % (07 November 2016)

Results and discussion

Remarks on result:
not measured/tested
Particle sizeopen allclose all
Key result
Percentile:
other: 5.15%
Mean:
150 µm
St. dev.:
0
Remarks on result:
other: standard deviation not provided in study report.
Key result
Percentile:
other: 24.43%
Mean:
120 µm
St. dev.:
0
Remarks on result:
other: standard deviation not provided in study report.
Key result
Percentile:
other: 31.27%
Mean:
105 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
standard deviation not provided in study report.
Key result
Percentile:
other: 54.56%
Mean:
75 µm
St. dev.:
0
Remarks on result:
other: standard deviation not provided in study report.
Key result
Percentile:
other: 86.72%
Mean:
45 µm
St. dev.:
0
Remarks on result:
other: standard deviation not provided in study report.
Key result
Percentile:
other: 93.00%
Mean:
37 µm
St. dev.:
0
Remarks on result:
other: standard deviation not provided in study report.

Applicant's summary and conclusion

Conclusions:
Granulometry of the test substance was conducted according to CIPAC MT 59, resulting in the following particle size distribution: The mean of residue for 150 μm sieve size obtained was 5.15%, for 120 μm sieve size obtained was 24.43%, for 105 μm sieve size obtained was 31.27%, for 75 μm sieve size obtained was 54.56%, for 45 μm sieve size obtained was 86.72% and for 37 μm sieve size obtained was 93.00%.
Executive summary:

Granulometry of the test substance was conducted according to CIPAC MT 59, resulting in the following particle size distribution: The mean of residue for 150 μm sieve size obtained was 5.15%, for 120 μm sieve size obtained was 24.43%, for 105 μm sieve size obtained was 31.27%, for 75 μm sieve size obtained was 54.56%, for 45 μm sieve size obtained was 86.72% and for 37 μm sieve size obtained was 93.00%.