Registration Dossier
Registration Dossier
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EC number: 223-267-7 | CAS number: 3794-83-0
Density
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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- EC Number:
- 223-267-7
- EC Name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- Cas Number:
- 3794-83-0
- Molecular formula:
- C2H8O7P2.4Na
- IUPAC Name:
- tetrasodium (1-hydroxyethane-1,1-diyl)bis(phosphonate)
- Reference substance name:
- BRIQUEST ADPA-60SH
- IUPAC Name:
- BRIQUEST ADPA-60SH
- Reference substance name:
- Tetrasodium (1-hydroxyethylidene) bisphosponate
- IUPAC Name:
- Tetrasodium (1-hydroxyethylidene) bisphosponate
- 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.
Constituent 1
Constituent 2
Constituent 3
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.
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