Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
pH of the substance was determined according to USP 38/NF 33 <791> Method, and conducted under good manufacturing practices (GMP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: USP 38/NF 34 <841> Method I
GLP compliance:
no
Other quality assurance:
other: conducted under good manufacturing practices (GMP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Results and discussion

pH value
Key result
pH value:
ca. 1.855
Temp.:
25 °C
Concentration:
other: 1 in 200 dilution
Remarks on result:
other:
Remarks:
Determined by measuring glass electrode

Applicant's summary and conclusion

Conclusions:
A 1:200 dilution of the Reaction Mass of 4-sulphophthalic acid and 3-sulphophthalic acid has a pH of 1.855