Bio molecules are less stable compared to Pharma drugs. Since proteins are notorious for stability many impurities gets generated on the stability.
If impurities are not available, we need to generate impurities by forcing degradation as per ICH Q2R1.
If a release limit of impurity is 0.5% for single and 2.0% of total impurities, How much % of impurity need to be generated in forced degradation (FDS) of Biomolecules?
Typically no more than 10-15% of the API. While there is no guidance, you do not want secondary degradation and a realistic degradation pathway that may occur in the commercial lots on the market.
Hi Bruce Neagle,
Thank you for reply. I belive if we go for 10 to 15% then unrealistic impurities (that may not forms on real life storage) may form in biomolecules.
Propencity of impurity formation in biomolecules is very high. E.g if you have biomolecule with 60 amino acid, by permutation and combination it may form hundreds of impurities.
In my previous life I performed 'forced degradation' for the nonapeptide (love hormone!) Oxytocin. I found 5 impurities. You will find a small change in pH will inactivate the peptide/protein/enzyme. In addition, deamidation (which occurs naturally) also inactivates the peptide and thus is an impurity.
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