Registration Dossier
Registration Dossier
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EC number: 212-391-7 | CAS number: 813-94-5
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-02 to 2010-06-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Principles of method if other than guideline:
- The pH measurements were carried out according to Jungbunzlauer Ladenburg GmbH method IIID-09/10. The calibration method is laid down in the equipment log books (eg IIIE-56). The report summarises the results for 815 samples manufactured between 2nd January 2008 and 14th June 2010 and analysed in Jungbunzlauer Ladenburg GmbH's quality control laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tricalcium dicitrate
- EC Number:
- 212-391-7
- EC Name:
- Tricalcium dicitrate
- Cas Number:
- 813-94-5
- Molecular formula:
- C6H8O7.3/2Ca
- IUPAC Name:
- tricalcium dicitrate
Constituent 1
Results and discussion
pH value
- pH value:
- 5.6
- Concentration:
- 2.5 other: % w/w (suspension)
- Remarks on result:
- other: ambient temperature
Any other information on results incl. tables
The mean pH value (2.5% w/w suspension in distilled CO2 free water) of tricalcium dicitrate is 5.6.
Mean: 5.64
Number of points: 815
Standard deviation: 0.04
Maximum: 5.92
Minimum: 5.37
Mean + 3SD: 5.88
Mean - 3SD: 5.39
Median: 5.64
Applicant's summary and conclusion
- Conclusions:
- A pH of 5.6 at 2.5% w/w (suspension) at 20-25°C was determined in a reliable study conducted according to generally accepted scientific principles.
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