Registration Dossier
Registration Dossier
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EC number: 208-901-2 | CAS number: 546-46-3
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-04-01 to 2009-12-01
- 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 47. The calibration method is laid down in SOP PA 50. The report summarises the results for 40 samples of fine particle size grades of trizinc dicitrate manufactured between 1st April and 1st December 2009 and analysed in Jungbunzlauer Austria AG's quality control laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Trizinc dicitrate
- EC Number:
- 208-901-2
- EC Name:
- Trizinc dicitrate
- Cas Number:
- 546-46-3
- Molecular formula:
- C6H8O7.3/2Zn
- IUPAC Name:
- trizinc dicitrate
Constituent 1
Results and discussion
pH value
- pH value:
- 5.4
- Concentration:
- 3 other: % w/w suspension in distilled water
- Remarks on result:
- other: ambient temperature
Any other information on results incl. tables
The mean pH value (3% w/w suspension in distilled water) of trisodium citrate is 5.4. Typical range is between 4.5 and 6.5.
Mean: 5.37
Number of points: 40
Standard deviation range: 0.16
Maximum: 6.50
Minimum: 4.58
Mean + 3SD: 7.57
Mean - 3SD: 3.16
Median: 4.83
Applicant's summary and conclusion
- Conclusions:
- A pH of 5.4 at 3% w/w (suspension in distilled water) at ambient temperature was determined in a reliable study conducted according to generally accepted scientific principles.
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