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Physical & Chemical properties

pH

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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:
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 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
Name:
Unnamed
Type:
Constituent

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.