Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted on 25 May 2010.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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 the relevant results. The study report was conclusive and done to a valid guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
Principles of method if other than guideline:
See Guideline.
GLP compliance:
no
Type of method:
air comparison pycnometer (for solids)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Sponsor's identification :BRIQUEST ADPA-60SH
Description : white powder
Chemical name :Tetrasodium (1-hydroxyethylidene) bisphosponate
Empirical formula :C2H8O7P2.4Na
CAS number : 3794-83-0
Batch number :A6SL20D1
Purity : 84.8% w/w
Date received :14 May 2010
Expiry date : 20 April 2012
Storage conditions :room temperature, in the dark

A Certificate of Analysis as supplied by the Sponsor see attachments.

Results and discussion

Density
Type:
relative density
Density:
1.53 other: Relative
Temp.:
20 °C

Any other information on results incl. tables

Results

Calibration

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

Determination

P1

P2

Volume (cm3)

Certified Volume (cm3)

Tolerance

(cm3)

A

17.363

8.607

56.7

56.6

± 0.5

B

17.298

8.575

56.7

56.6

± 0.5

Sample

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

Determination

P1

P2

Volume (cm3)

Density

(kg/m3)

A

17.146

7.332

27.5

1.53 x 103

B

17.074

7.300

27.4

1.53 x 103

Temperature:            22.0 ± 0.5°C
Mean density:           1.53 x 103 kg/m3
Relative density:       1.53

Applicant's summary and conclusion

Conclusions:
The relative density of the test item has been determined to be 1.53 at 20.0 ± 0.5°C.
Executive summary:

The relative density was determined to be 1.53 at 20.0 ± 0.5°C, using a gas comparison pycnoter, designed to be compatible with Method A3 Relative Density of Commission Regulation (EC) No 440/2008 of 30 May 2008.