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Diss Factsheets

Physical & Chemical properties

Density

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Reference
Endpoint:
density, other
Remarks:
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 performed using standard OECD test guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Qualifier:
according to guideline
Guideline:
other: the International Pharmacopoeia, fourth Edition, 2014.
GLP compliance:
no
Type of method:
pour and tap (for solids)
Key result
Type:
pour density
Density:
0.252 g/cm³
Temp.:
29.5 °C
Remarks on result:
other: at 978.2 hPa
Key result
Type:
tap density
Density:
0.348 g/cm³
Temp.:
29.5 °C
Remarks on result:
other: at 978.2 hPa

TEST ITEM DESCRIPTION AND RESULTS

FOR SOLIDS:

By Pour Density and Tapped Density Method:

Method Details

Observations

Remarks if, any

Guideline

OECD 109

1st

Reading

2nd Reading

 

 

Method

Test methods: Pour density and tapped density of powders recommended in

The International Pharmacopoeia, Fourth

Edition, 2014

 

 

Principle of method

Pour Density:It is the ratio of known weight of test item and its volume in graduated glass cylinder.

Tap Density:It is the difference between the

volume of test item measured before & after

tapping in the graduated glass cylinder.

 

 

Test temperature (°C)

-

29.6°C

29.5°C

Atmospheric pressure (in hPa)

-

978.5

977.9

Weight of test item (m)

 

10.082

10.080

Volume of measuring cylinder; readability in g

 

50ml; 1ml

50 ml;

1ml

Volume of test item

without tapping (V)

 

40

40

Volume of test item

after tapping ( V1)

After 10 tapping

35

43

 

After 50 tapping

30

28

 

After 100 tapping

30

28

 

After 250 tapping

-

-

 

After 500 tapping

-

-

 

After 750 tapping

-

-

*ρat=density of air at 27°C and 760 mm Hg pressure=0.001168 g/cm³

**Density of water referred from the Table 1 of the was method.

 

FOR SOLIDS:

By Pour Density and Tapped Density Method:

 

 

Parameters

 

Details

Calculated values

Average

Density

1st

Calculation

2nd

Calculation

Pour Density of test Item (g/cm³)

= m / V

 

0.2520

0.2520

0.2520

Tap density of test Item (g/cm³)

= m / V1

 

0.3360

0.3600

0.3480

 

Conclusions:
The density of test chemical was determined following OECD Guideline 109 (Density of Liquids and Solids) and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014 . The mean pour density and tapped density of the test chemical was determined to be 0.2520 g/cm³ and 0.3480 g/cm³ at 29.5°C and 978.2 hPa, respectively.
Executive summary:

The density of test substance was concluded following OECD Guideline 109 and according to the "Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus. The mean pour density and tapped density of test substance was determined to be 0.2520 g/cm³ and 0.3480 g/cm³ at 29.5°C and 978.2 hPa, respectively.

Description of key information

Based on the available data from study report,the density of test substance was concluded following OECD Guideline 109 and according to the "Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus. The mean pour density and tapped density of test substance was determined to be 0.2520 g/cm³ and 0.3480 g/cm³ at 29.5°C and 978.2 hPa, respectively.

Key value for chemical safety assessment

Relative density at 20C:
0.252

Additional information

Based on the available data from study report,the density of test substance was concluded following OECD Guideline 109 and according to the "Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus. The mean pour density and tapped density of test substance was determined to be 0.2520 g/cm³ and 0.3480 g/cm³ at 29.5°C and 978.2 hPa, respectively.