2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt

Density

Link to relevant study record(s)

Reference

Endpoint:

density, other

Remarks:

pour and tap 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 OECD test guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 109 (Density of Liquids and Solids)

Qualifier:

according to guideline

Guideline:

other: method recommended in the International Pharmacopoeia, fourth Edition, 2014

GLP compliance:

no

Type of method:

pour and tap (for solids)

Key result

Type:

pour density

Density:

0.488 g/cm³

Temp.:

25 °C

Remarks on result:

other: at 964.65 hPa

Key result

Type:

tap density

Density:

0.742 g/cm³

Temp.:

25 °C

Remarks on result:

other: at 964.65 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)		25 °C	25°C
Atmospheric pressure (in hPa)		965.2 hPa	964.1 hPa
Weight of test item(m)		20.006	20.004
Volume of measuring cylinder; readability in ml		250 ml;2ml	250 ml;2ml
Volume of test item without tapping (V)		40	42
Volume of test item after tapping ( V1)	After 10 tapping	30	30
	After 50 tapping	28	26
	After 100 tapping	28	26
	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

CALCULATIONS:

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	0.5001	0.4762	0.4882
Tap density of test Item (g/cm³)	= m V1	0.7145	0.7693	0.7419

Conclusions:

The density of test chemical was determined following OECD guideline 109 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 0.4882 g/cm³ and 0.7419 g/cm³ at 25°C and 964.65 hPa.

Executive summary:

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 0.4882 g/cm³ and 0.7419 g/cm³ at 25°C and 964.65 hPa.

Description of key information

On the basis of available data from study report, 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 0.4882 g/cm³ and 0.7419 g/cm³ at 25°C and 964.65 hPa.

Key value for chemical safety assessment

Relative density at 20C:

0.488

Additional information

On the basis of available data from study report, 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 0.4882 g/cm³ and 0.7419 g/cm³ at 25°C and 964.65 hPa.