Registration Dossier
Registration Dossier
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EC number: 212-755-5 | CAS number: 866-84-2
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-09 to 2010-05-18
- 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 2142 samples manufactured between 9th January 2008 and 18th May 2010 and analysed in Jungbunzlauer Ladenburg GmbH's quality control laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tripotassium citrate
- EC Number:
- 212-755-5
- EC Name:
- Tripotassium citrate
- Cas Number:
- 866-84-2
- Molecular formula:
- C6H8O7.3K
- IUPAC Name:
- tripotassium citrate
Constituent 1
Results and discussion
pH value
- pH value:
- 8.7
- Concentration:
- 5 other: % w/w
- Remarks on result:
- other: ambient temperature
Any other information on results incl. tables
The mean pH value (5% w/w in distilled water) of tripotassium citrate is 8.7.
Mean: 8.74
Number of points: 2142
Standard deviation: 0.04
Maximum: 8.90
Minimum: 8.30
Mean + 3SD: 8.95
Mean - 3SD: 8.53
Median: 8.74
Applicant's summary and conclusion
- Conclusions:
- A pH of 8.7 at 5% w/w at ambient temperature was determined in a reliable study conducted according to generally accepted scientific principles.
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