Registration Dossier
Registration Dossier
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EC number: 228-845-2 | CAS number: 6362-79-4
Additional physico-chemical information
Administrative data
- Endpoint:
- other: purity determination
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: There is no standard internationally recognized protocol for this endpoint. The study was well documented and followed recognized GLP procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
- Principles of method if other than guideline:
- Although no guideline is available for this test, a company validated protocol was followed with full GLP compliance.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium hydrogen-5-sulphoisophthalate
- EC Number:
- 228-845-2
- EC Name:
- Sodium hydrogen-5-sulphoisophthalate
- Cas Number:
- 6362-79-4
- Molecular formula:
- C8H6O7S.Na
- IUPAC Name:
- Sodium 3,5-dicarboxybenzenesulfonate
- Details on test material:
- - Name of test material: 5-(sodiosulfo)isophthalic acid
- Appearance: white powder
- Lot/batch No.: Sample reference number 65517
- Receipt date: July 12, 1996
- Other: PM No. 03278-00
Constituent 1
Results and discussion
- Results:
- The purity was determined to be 93.5 weight percent.
Any other information on results incl. tables
Results
| Sample ID | Weight % Purity |
| 1 | 93.0 |
| 2 | 93.6 |
| 3 | 93.8 |
| mean | 93.5 |
| standard deviation | 0.42 |
| % CV | 0.449 |
Applicant's summary and conclusion
- Conclusions:
- The mean weight percent purity as determined by titration was 93.5.
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