Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
pH of the substance was determined according to USP 40/NF 35 <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 40/NF 35 <791>
GLP compliance:
no
Remarks:
conducted under good manufacturing practices (GMP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
additive
Type:
impurity
Test material form:
liquid: viscous
Details on test material:
- Other: R-9817

Results and discussion

pH value
Key result
pH value:
ca. 7.36
Temp.:
19.9 °C
Concentration:
ca. 200 mg/L
Remarks on result:
other: Determined with pH indicater paper. 1.0 to 200.0 dilution in 200 proof ethylalcohol

Applicant's summary and conclusion

Conclusions:
Benzene sulfonic acid, di-C10-14-alkyl derivs., sodium salts has a pH of 7.36 determined with pH indicator paper.