Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-yhdroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodiu2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino) -2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate

Density

Link to relevant study record(s)

Reference

Endpoint:

density, other

Remarks:

pour density and tapped density

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-10-2018 – 06-10-2018

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:

OECD Guideline 109 (Density of Liquids and Solids)

Principles of method if other than guideline:

The density of Test item Reaction mass of hexasodium 2 -[{8 -amino-7 -[(5 -{[4 -chloro-6 -(4 -{[2 -(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5 -triazin-2 -yl]amino}-2 -sulfonatophenyl)diazenyl]-1 -hydroxy-3,6 -disulfonato-2 -naphthyl}diazenyl]naphthalene-1,5 -disulfonate and pentasodium 2 -[(8 -amino-7 -{[5 -({4 -chloro-6 -[4 -(vinylsulfonyl)anilino]-1,3,5 -triazin-2 -yl}amino)-2 -sulfonatophenyl]diazenyl}-1 -hydroxy-3,6 -disulfonato-2 -naphthyl)diazenyl]naphthalene-1,5 -disulfonate (EC no.: 617 -054 -1) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014.

GLP compliance:

no

Type of method:

pour and tap (for solids)

Specific details on test material used for the study:

IUPAC name : Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-hydroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodium 2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate
Mol. formula: C37H28ClN10NaO22S7
Molecular weight : 1247.57 g/mol
Smiles : Nc1c(N=Nc2cc(Nc3nc(Nc4ccc(S(=O)(=O)CCOS(O)(=O)=O)cc4)nc(Cl)n3)ccc2S(O)(=O)=O)c(S(O)(=O)=O)cc2cc(S(O)(=O)=O)c(N=Nc3ccc4c(S(O)(=O)=O)cccc4c3S(=O)(=O)O{-}.[Na]{+})c(O)c12

Key result

Type:

pour density

Density:

0.572 g/cm³

Temp.:

25 °C

Remarks on result:

other: At 974.6 hPa.

Key result

Type:

tap density

Density:

0.69 g/cm³

Temp.:

25 °C

Remarks on result:

other: At 974.6 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)		974.8 hPa	974.4 hPa
Weight of test item(m)		20.004	20.002
Volume of measuring cylinder; readability in g		50 ml;1ml	50 ml;1ml
Volume of test item without tapping (V)		35	35
Volume of test item after tapping ( V1)	After 10 tapping	32	30
	After 50 tapping	29	29
	After 100 tapping	29	29
	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.

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	0.5715	0.5714	0.5715
Tap density of test Item (g/cm³)	= m V1	0.6897	0.6897	0.6897

Conclusions:

The density of Test item Reaction mass of hexasodium 2 -[{8 -amino-7 -[(5 -{[4 -chloro-6 -(4 -{[2 -(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5 -triazin-2 -yl]amino}-2 -sulfonatophenyl)diazenyl]-1 -hydroxy-3,6 -disulfonato-2 -naphthyl}diazenyl]naphthalene-1,5 -disulfonate and pentasodium 2 -[(8 -amino-7 -{[5 -({4 -chloro-6 -[4 -(vinylsulfonyl)anilino]-1,3,5 -triazin-2 -yl}amino)-2 -sulfonatophenyl]diazenyl}-1 -hydroxy-3,6 -disulfonato-2 -naphthyl)diazenyl]naphthalene-1,5 -disulfonate (EC no.: 617 -054 -1)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 item was determine to be 0.5715 g/cm³ and 0.6897 g/cm³ at 25°C and 974.6 hPa.

Executive summary:

The density of Test item Reaction mass of hexasodium 2 -[{8 -amino-7 -[(5 -{[4 -chloro-6 -(4 -{[2 -(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5 -triazin-2 -yl]amino}-2 -sulfonatophenyl)diazenyl]-1 -hydroxy-3,6 -disulfonato-2 -naphthyl}diazenyl]naphthalene-1,5 -disulfonate and pentasodium 2 -[(8 -amino-7 -{[5 -({4 -chloro-6 -[4 -(vinylsulfonyl)anilino]-1,3,5 -triazin-2 -yl}amino)-2 -sulfonatophenyl]diazenyl}-1 -hydroxy-3,6 -disulfonato-2 -naphthyl)diazenyl]naphthalene-1,5 -disulfonate (EC no.: 617 -054 -1)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 item was determine to be 0.5715 g/cm³ and 0.6897 g/cm³ at 25°C and 974.6 hPa.

Description of key information

The density of Test item Reaction mass of hexasodium 2 -[{8 -amino-7 -[(5 -{[4 -chloro-6 -(4 -{[2 -(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5 -triazin-2 -yl]amino}-2 -sulfonatophenyl)diazenyl]-1 -hydroxy-3,6 -disulfonato-2 -naphthyl}diazenyl]naphthalene-1,5 -disulfonate and pentasodium 2 -[(8 -amino-7 -{[5 -({4 -chloro-6 -[4 -(vinylsulfonyl)anilino]-1,3,5 -triazin-2 -yl}amino)-2 -sulfonatophenyl]diazenyl}-1 -hydroxy-3,6 -disulfonato-2 -naphthyl)diazenyl]naphthalene-1,5 -disulfonate (EC no.: 617 -054 -1)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 item was determine to be 0.5715 g/cm³ and 0.6897 g/cm³ at 25°C and 974.6 hPa.

Additional information

The density of Test item Reaction mass of hexasodium 2 -[{8 -amino-7 -[(5 -{[4 -chloro-6 -(4 -{[2 -(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5 -triazin-2 -yl]amino}-2 -sulfonatophenyl)diazenyl]-1 -hydroxy-3,6 -disulfonato-2 -naphthyl}diazenyl]naphthalene-1,5 -disulfonate and pentasodium 2 -[(8 -amino-7 -{[5 -({4 -chloro-6 -[4 -(vinylsulfonyl)anilino]-1,3,5 -triazin-2 -yl}amino)-2 -sulfonatophenyl]diazenyl}-1 -hydroxy-3,6 -disulfonato-2 -naphthyl)diazenyl]naphthalene-1,5 -disulfonate (EC no.: 617 -054 -1)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 item was determine to be 0.5715 g/cm³ and 0.6897 g/cm³ at 25°C and 974.6 hPa.