Reaction product of 3-[4-(2-aminoethylamino)-6-(4-sulfoanilino)-1,3,5-heterocycle-2-ylamino]benzensulfonic acid, ammonia water, sodium chloride and {mixture of [poly(1~4)chlorosulfonylphthalocyaninato-N29,N30,N31,N32]copper(II), [poly(1~3)chlorosulfonyl (tribenzo[b,g,l]pyrido[2,3-q]-5,10,15,20-tetraazaporphyrinato-N21,N22,N23,N24)]copper(II),[poly(1~2)chlorosulfonyl(dibenzol[b,g(or b,l)dipyrido[2,3(or 3,2)-l,q (or g,q)]-5,10,15,20-tetraazaporphyrinato-N21,N22,N23,N24)] copper(II) and [monochlorosulfonyl(benzo[b]tripyridol[2,3(or 3,2)-g,lq]-5,10,15,20- tetraazaporphyrinato- N21,N22,N23,N24)] copper(II)

Density

Administrative data

Endpoint:

relative density

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 January 2009 to 07 February 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.3 (Relative Density)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 19 August 2008; Date of signature: 04 March 2009

Type of method:

pycnometer method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification : H-CB sodium salt
Description : blue solid
Purity : 94.8%
Lot number : MB-2
Date received : 04 December 2008
Storage conditions : room temperature in the dark

Results and discussion

Density

Type:

relative density

Density:

1.74

Temp.:

20 °C

Any other information on results incl. tables

Calibration

The pressure readings (P₁and P₂) and the calculated volume for the calibration ball are shown in the following table:

 

Table 1

 

Determination	P1	P2	Volume (cm^3)	Certified Volume (cm^3)	Tolerance (cm^3)
A	17.031	8.430	56.4	56.6	+/- 0.5
B	17.535	8.679	56.4	56.6	+/- 0.5

 

Sample

The pressure readings, calculated volumes and density values obtained for the test material are shown in the following table:

 

Table 2

 

Determination	P1	P2	Volume (cm^3)	Density (kg/m^3)
A	17.521	7.499	27.7	1.74 x 10^3
B	17.113	7.119	21.5	1.74 x 10^3

 

Temperature:              20.0 +/- 0.5^oC

Mean density:             1.74 x 10³kg/m³

Relative density:         1.74

Applicant's summary and conclusion

Conclusions:

The relative density of the test material has been determined to be 1.74 at 20.0 +/- 0.5 Deg C

Executive summary:

1.74 at 20.0 +/- 0.5 Deg C, using a gas comparison pycnometer, result was obtained according to Method A3 Relative Density of Commission Regulation (EC) No 440/2008 of 30 May 2008.