Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
not specified
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Valproic Acid and Sodium Valproate: Comprehensive Profile
Author:
Ibrahim A. Alsarra, M. Al-Omar, and F. Belal
Year:
2005
Bibliographic source:
Profiles Of Drug Substances, Excipients, And Related Methodology volume 32

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No data on method available

Test material

Constituent 1
Reference substance name:
Valproic acid
IUPAC Name:
Valproic acid
Constituent 2
Chemical structure
Reference substance name:
2-propylvaleric acid
EC Number:
202-777-3
EC Name:
2-propylvaleric acid
Cas Number:
99-66-1
Molecular formula:
C8H16O2
IUPAC Name:
2-propylpentanoic acid

Results and discussion

pH value
pH value:
>= 7 - <= 8

Applicant's summary and conclusion

Conclusions:
USP solution of valproic acid has a pH of 7-8