Identification and confirmation of degradation products
RD&C analyzes and evaluates degradation products using its system impurity analysis approach and designs study plans for selective compound accumulation and subsequent structure elucidation.
Elemental Impurities
RD&C supports the risk assessment process for elemental impurities according to ICH Q3D. RD&C identifies and elucidates sources of impurities. A risk minimization and control proposal will be provided.
Residual impurity levels – fate and purge discussion
RD&C analyzes and evaluates all potential impurities in the manufacturing process and discusses residual impurity levels by applying purge factors and fate considerations.
(Potential) Mutagenic impurities
RD&C identifies, classifies, and evaluates (potential) mutagenic impurities by authority approved in silico methods including eventual Threshold of Toxicological Concern (TTC) and purge factor discussions. A risk assessment report and a concept for control strategies will be developed and implemented.
Statistical analysis of stability and forced degradation studies
RD&C offers broad experience in statistics to support its clients in evaluating relevant data in a regulatory compliant manner. RD&C analyzes reaction and degradation kinetics to predict impurity formation and composition or degradation kinetics influencing efficacy, safety, and shelf life of a drug.
