Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final ...

Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

Oxidation is a major degradation pathway for active pharmaceutical ingredients (APIs), particularly in solid dosage forms. It can reduce efficacy, generate toxic by-products, and shorten shelf ...