RD&C offers a holistic system impurity analysis approach considering all parameters of drug substance, drug product and the manufacturing process, and introduces valuable expertise and information for time and cost efficient impurity profiling.
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.
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.