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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:
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:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
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%).