Four out of the top reasons for CEP rejection by the EDQM are impurity issues (EMA 2009).

Deficiencies on impurity profiles during process development are among the top then reasons for revenue losses through delayed product launch, decreased shelf life, etc.

RD&C provides support in planning, implementation, and management of impurity solutions:

Theoretical evaluation of the synthesis pathway of the drug substance and pharmaceutical development of the drug product for the prediction and probability of the emergence of certain impurities


Quality-by-design (QbD) approaches for process development and optimization


Strategies and recommendations for avoiding, analyzing and monitoring of such by- and degradation product


Managment of impurity analytics and structure elucidation


Synthesis and certification of reference material for qualification

In silico toxicologal assessment


Systemic impurity analysis


Proposal of most time-efficient and cost-saving ways to satisfy scientific, strategic, and regulatory requirements


Individual solutions by a standardized project management


Expert reports and proposal of a regulatory compliant argumentation line

Documentation of impurities for registration and variation reports.