Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dissociation constant
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The isoelectric point (pI) of a protein is the pH at which a particular protein carries no net electrical charge in the statistical mean. The pI can be calculated as the average of the pKa’s in the protein.
The PI of the batches used in the studies of this dossier range from 7.9-9.2.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion