Nitrosamine impurity control strategies in oral solid dosage forms: a systematic review of regulatory guidance 2018–2026
Topics: Medicinal and pharmaceutical chemistry, Adaptive, platform, basket and umbrella trials, Bioethics and informed consent
A reversed-phase HPLC method was developed and validated according to ICH Q2(R2) for the simultaneous quantification of two active ingredients and their principal degradants. Forced degradation under acid, base, oxidative, thermal and photolytic stress demonstrated specificity…
