Registration Dossier

Physical & Chemical properties

pH

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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:
2010
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
Name:
Unnamed
Type:
Constituent

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.