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Density

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Reference
Endpoint:
density, other
Remarks:
density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09-10-2018 – 09-10-2018
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:
OECD Guideline 109 (Density of Liquids and Solids)
Principles of method if other than guideline:
The density of Test item 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: 2-[[6-[[4-Chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulfo-2-naphthalenyl]azo]-1,5-naphthalenedisulfonic acid tetrasodium salt
- Mol. formula: C31H20ClN7Na4O16S5
- Molecular Weight: 1034.275 g/mole
- InChI: 1S/C31H24ClN7O16S5.4Na/c32-29-35-30(33-17-4-7-19(8-5-17)56(41,42)13-12-55-60(52,53)54)37-31(36-29)34-18-6-9-20-16(14-18)15-25(58(46,47)48)26(27(20)40)39-38-23-11-10-21-22
(28(23)59(49,50)51)2-1-3-24(21)57(43,44)45;;;;/h1-11,14-15,40H,12-13H2,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54)(H2,33,34,35,36,37);;;;/q;4*+1/p-4/b39-38+;;;;
- Smiles:c1cc2c(ccc(c2S(=O)(=O)[O-])N=Nc3c(cc4cc(ccc4c3O)Nc5nc(nc(n5)Cl)Nc6ccc(cc6)S(=O)(=O)CCOS(=O)(=O)[O-])S(=O)(=O)[O-])c(c1)S(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+]
- Appearance : Solid
Key result
Type:
pour density
Density:
0.45 g/cm³
Temp.:
20 °C
Remarks on result:
other: 972.3 hPa.
Key result
Type:
tap density
Density:
0.578 g/cm³
Temp.:
20 °C
Remarks on result:
other: 972.3 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)

 

 27°C

27°C

 Atmospheric

pressure (in hPa)

 

972.8 hPa 

971.9 hPa

Weight of test

item(m)

 

 20.237

 20.233

 Volume of measuring

cylinder; readability

in g

 

50 ml;1ml 

 50 ml;1ml

 Volume of test item

without tapping (V)

 

44 

 46

 Volume of test item

after tapping ( V1)

After 10 tapping 

 40

 42

   After 50 tapping  36 36 
   After 100 tapping  35  35
   After 250 tapping  35  35
   After 500 tapping  -
   After 750 Tapping  -

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

 

0.4599 

 0.4398

 0.4498

 Tap density of test Item

(g/cm³)

= m

V1

 

0.5782 

0.5780 

 0.5781

Conclusions:
The density of Test item 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 0.4498 g/cm³ and 0.5781 g/cm³ at 20°C and 972.3 hPa.
Executive summary:

The density of Test item 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 0.4498 g/cm³ and 0.5781 g/cm³ at 20°C and 972.3 hPa.

Description of key information

The density of Test item 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 0.4498 g/cm³ and 0.5781 g/cm³ at 20°C and 972.3 hPa.

Key value for chemical safety assessment

Additional information

The density of Test item 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 0.4498 g/cm³ and 0.5781 g/cm³ at 20°C and 972.3 hPa.