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Diss Factsheets

Physical & Chemical properties

Density

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bulk density
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed using standard test guidelines
Qualifier:
according to guideline
Guideline:
other: Standard method recommended in the International Pharmacopoeia, fourth Edition, 2014
Principles of method if other than guideline:
Determination of the bulk and tap density of test chemical.
GLP compliance:
no
Type of method:
pour and tap (for solids)
Key result
Type:
bulk density
Density:
0.312 g/cm³
Temp.:
22.8 °C
Key result
Type:
tap density
Density:
0.5 g/cm³
Temp.:
22.8 °C

TEST DESCRIPTION AND RESULTS

Method Details

Observations

Remarks if, any

Guideline

“Test methods: Bulk density and tapped density of powders”recommended inThe International Pharmacopoeia, Fourth Edition, 2014[1]

-

 

Principle of method

Bulk and Tap densities are determined by measuring the volume of a known mass of powder into a graduated cylinder without and after tapping, respectively.

-

Method

Measurement in a Graduated Cylinder and Bulk Density Apparatus

-

Test temperature (°C)

-

22.8°C

Weight (mass) of test substance (g)

m

10 gm

Volume of test substance in cylinder without tapping (ml)

v

32 ml

Volume of test substance in cylinder after tapping (ml)

v1

20 ml

 

CALCULATIONS:

Parameters

Details

Calculated Values (RESULT)

Bulk Density of test substance (g/cm3)

= m
    v

0.3125g/cm3

Tap density of test substance (g/cm3)

= m
    v1

0.5g/cm3

Conclusions:
The bulk and tap density of test chemical was determined following the standard method recommended in the International Pharmacopoeia, fourth Edition, 2014. Method followed was pour and tap method. The bulk and tap density of the test chemical was determined to be 0.3125 gm/cm3 and 0.5 gm/cm3 at 22.8°C.
Executive summary:

The bulk and tap density of test chemical was determined following the standard method recommended in the International Pharmacopoeia, fourth Edition, 2014. Method followed was pour and tap method. The bulk and tap density of test chemical was determined to be 0.3125 gm/cm3 and 0.5 gm/cm3 at 22.8°C.

Description of key information

Based on the data from study report, the bulk and tap density of test chemical was determined following the standard method recommended in the International Pharmacopoeia, fourth Edition, 2014. Method followed was pour and tap method. The bulk and tap density of test chemical was determined to be 0.3125 gm/cm3 and 0.5 gm/cm3 at 22.8°C.

Key value for chemical safety assessment

Relative density at 20C:
0.5

Additional information

Based on the data from study report, the bulk and tap density of test chemical was determined following the standard method recommended in the International Pharmacopoeia, fourth Edition, 2014. Method followed was pour and tap method. The bulk and tap density of test chemical was determined to be 0.3125 gm/cm3 and 0.5 gm/cm3 at 22.8°C.