Managing impurities in pharmaceutical manufacturing

Impurities in pharmaceuticals can compromise patient safety — causing increased cancer risk, unpredictable adverse effects, or reduced therapeutic efficacy. However issues with forced degradation studies arise from undefined endpoints resulting in inconsistencies in both design and interpretation.

Explore this resource as it responds to this commonly faced challenge by acting as a practical companion, to existing regulatory guidance, and discusses how recent advances in analytical science can be used for reliable quantification of impurities at trace levels, helping ensure the design and manufacture of safer medicines.