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EC number: 459-550-9 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test are made according to other guideline: IP3.6 gravimetry
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: IP 3.6
- Deviations:
- no
- Principles of method if other than guideline:
- The method is based on the determination of the part by weight obtained by sieving the sample to the sieves. The method is suitable for determining the size distribution of the sample from 0,01% to 99,5%.
- GLP compliance:
- yes
- Type of distribution:
- other: Gravimetry analyse
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Product Name: L-Carnitine-L-Tartrate
Producer: Chengda Pharmaceuticals Co., Ltd., China
Batch No.: 1001003
Manufacturing Date: 2010.01.03
Expiry Date: 2012.01.02
Results and discussion
Particle size
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- >= 800 µm
- Distribution:
- 0.59 %
- Remarks on result:
- other: Uncertainty 5%
- No.:
- #2
- Size:
- >= 250 µm
- Distribution:
- 77.35 %
- Remarks on result:
- other: Uncertainty 5%
- No.:
- #3
- Size:
- >= 125 µm
- Distribution:
- 21.92 %
- Remarks on result:
- other: Uncertainty 5%
- No.:
- #4
- Size:
- >= 100 µm
- Distribution:
- 0.1 %
- Remarks on result:
- other: Uncertainty 5%
Any other information on results incl. tables
Granulometry
1.1 Subject and scope of the IP 3.6
The prescription is being applied for determination of size distribution in these types of materials:
- Solid materials - soils and geological materials (A)
- Fertilizers, soil adjuvants, growing mediums (H)
1.2 Principle of the method
The method is based on the determination of the percentage of each sieve fraction with respect to
total mass of fractions obtained by sieving the sample through the sieves.
1.3 Field of application
The method is suitable for determining of the size distribution of the sample from 0.01% to 99.5%.
1.4 Interference effects
No interference effects were determined.
1.5 Apparatus
- Routine laboratory equipment
- A sieve device (type ST - 4)
- Sieves with round or square holes
- Scales
1.6 Working process
The device saved screens with the required holes. Sample of 200 to 500 grams is weighed according
to the type of standards or the requirements of customers with an accuracy of 0.1. Sample is placed
on the top sieve and is being passed through sieve during the sieving time necessary for completing
sieving of the sample. After finishing of sieving, the whole fraction is taken from each sieve and
weighed (accuracy of measurement 0.1 g). Particles retained in the sieve (in holes) are added to the
oversize fraction. Demolition of lumps and particles is not allowed. Losses by the sieving shall not
exceed 1%.
1.7 Calculation
Mass fraction (x) percentage is calculated as follows:
Mi. 100
x = -----------------
M
M is the mass of weighed sample in g
Mi is the mass proportion of the site in g.
1.8 Expression and presentation of results
Results are expressed as %.
1.9 The limit of quantification methods and uncertainty
The limit of quantification of the method is 0.01%.
Uncertainty of measurement in the working range is as follows:
0.01 - 99.5% 5%
Applicant's summary and conclusion
- Conclusions:
- 99% of the particles are between 100 µm and 800 µm.
99.9% of the particles are over 100 µm (error 0.5%).
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