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:
2008-01-09 to 2010-05-18
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 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 2142 samples manufactured between 9th January 2008 and 18th May 2010 and analysed in Jungbunzlauer Ladenburg GmbH's quality control laboratory.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

pH value
pH value:
8.7
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 tripotassium citrate is 8.7.

Mean: 8.74

Number of points: 2142

Standard deviation: 0.04

Maximum: 8.90

Minimum: 8.30

Mean + 3SD: 8.95

Mean - 3SD: 8.53

Median: 8.74

Applicant's summary and conclusion

Conclusions:
A pH of 8.7 at 5% w/w at ambient temperature was determined in a reliable study conducted according to generally accepted scientific principles.