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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Pharmacopoeia (8.8, 2016) 2.2.3
Version / remarks:
8.8, 2016
Deviations:
no
GLP compliance:
no
Other quality assurance:
other: ISO 9001:2008

Test material

Specific details on test material used for the study:
Batch number: 16031421 (aqueous solutions made by sponsor)

Reagents

Reagent:
water

Titration of acidity and alkalinity

Details on titrant used:
pH-Meter Metrohm 827 pH lab equipped with a LL Unitrode Pt 1000 (including temperature compensation, Serial No 00183873)

Results and discussion

pH value
Key result
pH value:
0.81
Temp.:
20 °C
Concentration:
1 other: molar

Any other information on results incl. tables

Test parameter Temperature (temperature compensation in apparatus): 20 °C (293 K)

Last calibration of the apparatus (standards pH 4, 7 and 9): July 11, 2016

pH Value of 0.1 n HCl (solution made by sponsor): 1.04

pH Value of 1 n HCl (solution made by sponsor): 0.00

pH Value of 0.1 m solution of test substance (solution made by sponsor): 1.53

pH Value of 0.5 m solution of test substance (solution made by sponsor): 1.07

pH Value of 1 m solution of test substance (solution made by sponsor): 0.81

pH Value of 2 m solution of test substance (information of the sponsor): 0.44

Applicant's summary and conclusion