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EC number: 205-086-5 | CAS number: 132-98-9
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18-21/06/2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Remarks:
- Fraunhofer
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- Batch: B526734
- Key result
- Percentile:
- D10
- Mean:
- ca. 2.296 µm
- St. dev.:
- 10.41
- Key result
- Percentile:
- D50
- Mean:
- ca. 10.34 µm
- St. dev.:
- 10.41
- Key result
- Percentile:
- D90
- Mean:
- ca. 28.31 µm
- St. dev.:
- 10.41
- Conclusions:
- D(50) of Penicillin V Potassium is 10.34 µm
- Executive summary:
Particle Size distrubution results, measured by means of a LS Particle Size Analyzer (Fraunhofer optical method) is as follow:
D(10): 2.296 µm - D(50): 10.34 µm - D(90): 28.31 µm
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 May 2019 - 05 June 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- • CIPAC MT 59 Sieve Analysis
• CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules
• CIPAC MT 169 Tap Density of Water Dispersible Granules - Principles of method if other than guideline:
- Sieve analysis consists of the quantitative separation of test item into fractions of different particle size ranges by using of machine sieving method.
The test item was weighed into a beaker (W g) and poured into the measuring cylinder and fitted the rubber bung into the cylinder without jolting.
It was carefully put in the dropping box and the timing device was started.
With the thumb and forefinger of one hand the upper part of the cylinder was held and, during 1 second it was lifted up to 25 mm height. At the beginning of the next second, the cylinder was smartly released by quickly and completely withdrawing the thumb and forefinger. 50 counted drops were completed.
Then the cylinder was removed immediately from the dropping box, the volume was noted to the nearest 1 mL (V mL). - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- No.:
- #1
- Size:
- < 45 µm
- Distribution:
- ca. 0.03 %
- No.:
- #2
- Size:
- >= 45 - < 63 µm
- Distribution:
- ca. 0.15 %
- No.:
- #3
- Size:
- >= 63 - < 100 µm
- Distribution:
- ca. 0.04 %
- No.:
- #4
- Size:
- >= 100 - < 250 µm
- Distribution:
- ca. 0.39 %
- No.:
- #5
- Size:
- >= 250 - < 500 µm
- Distribution:
- ca. 3.3 %
- No.:
- #6
- Size:
- >= 500 - < 1 000 µm
- Distribution:
- ca. 20.92 %
- No.:
- #7
- Size:
- >= 1 000 - < 2 000 µm
- Distribution:
- ca. 75.17 %
- No.:
- #8
- Size:
- >= 2 000 - < 4 000 µm
- Distribution:
- ca. 0.01 %
- No.:
- #9
- Size:
- > 4 000 µm
- Distribution:
- ca. 0 %
- Conclusions:
- Sieve analysis consists of the quantitative separation of test item into fractions of different particle size ranges by using of machine sieving method.
- Executive summary:
Machine sieving test was carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.
The sieve size (µm) which passes less than 10 % of the charged substance is 250 µm.
The sieve size (µm) which passes more than 95 % of the charged substance is 2000µm
The mean particle size (by mass) is between 250 µm and 2000 µm.
Referenceopen allclose all
Description of key information
Particle Size distribution of Penicillin V Potassium has been analyzed with two techniques:
A Machine sieving test carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.
And a Beckman Coulter Laser using Fraunhofer Optical Method.
Additional information
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