Registration Dossier
Registration Dossier
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EC number: 200-675-3 | CAS number: 68-04-2
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-01 to 2010-06-19
- 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 Austria AG SOP PA 55. The calibration method is laid down in SOP PA 50. The report summarises the results for 1166 samples manufactured between 1st January 2008 and 19th June 2010 and analysed in Jungbunzlauer Austria AG's quality control laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium citrate
- EC Number:
- 200-675-3
- EC Name:
- Trisodium citrate
- Cas Number:
- 68-04-2
- Molecular formula:
- C6H8O7.3Na
- IUPAC Name:
- trisodium citrate
Constituent 1
Results and discussion
pH value
- pH value:
- 8.4
- 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 trisodium citrate is 8.4.
Mean: 8.37
Number of points: 1166
Standard deviation: 0.07
Maximum: 8.66
Minimum: 7.77
Mean + 3SD: 8.72
Mean - 3SD: 8.02
Median: 8.39
Applicant's summary and conclusion
- Conclusions:
- A pH of 8.4 at 5% w/w at ambient temperature was determined in a reliable study conducted according to generally accepted scientific principles.
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