Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Enzymes are polymers built of different combinations of the 20 common amino acids in various length and order. The amino acids sequence determines the structure of the enzyme since at biological conditions the structure of this polymer is defined by the energy minimum fold. The enzyme fold and structure is held together primarily by hydrogen bonds, hydrophobic interactions, ion bonds and van der Waals forces between the different amino acids and cofactors. When heating the enzymes above the biological conditions, typically 80°C and higher, the attracting forces within the enzymes are broken, the fold is disrupted and the enzyme denatures. Denatured enzymes lose their activity and typically coagulate. Thus, a classical melting point is not relevant for enzymes.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion