Registration Dossier
Registration Dossier
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EC number: 242-734-6 | CAS number: 18996-35-5
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-02-19 to 2010-03-19
- 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 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 628 samples manufactured between 19th February 2007 and 19th March 2010 and analysed in Jungbunzlauer's quality control laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium dihydrogen citrate
- EC Number:
- 242-734-6
- EC Name:
- Sodium dihydrogen citrate
- Cas Number:
- 18996-35-5
- Molecular formula:
- C6H8O7.Na
- IUPAC Name:
- dihydrogen sodium citrate
Constituent 1
Results and discussion
pH value
- pH value:
- 3.8
- Concentration:
- 1 other: % w/w
- Remarks on result:
- other: ambient temperature
Any other information on results incl. tables
The mean pH value (1% w/w in distilled water) of sodium dihydrogen citrate is 3.8.
Each individual pH value is traceable via the Certificate of analysis and the corresponding raw data sheet. Raw data sheets are maintained for the shelf life plus 1 year.
Mean: 3.795
Number of points: 628
Standard deviation: 0.006
Maximum: 3.810
Minimum: 3.770
Mean + 3SD: 3.825
Mean - 3SD: 3.764
Median: 3.800
Applicant's summary and conclusion
- Conclusions:
- A pH of 3.8 at 1% w/w at ambient temperature was determined in a reliable study conducted according to generally accepted scientific principles.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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