European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 95

Pharmaceutical Food and Drug Administration Medicine FDA 95

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

Medicine 104

Medicine Food and Drug Administration Transportation Distribution 104

European Pharmaceutical Review

SEPTEMBER 25, 2023

This has led to applications with biopharmaceutical formulations and protein investigations. Of particular interest is the potential of using NMR relaxometry as a point of receipt technique to satisfy regulatory identity testing requirements for active pharmaceutical ingredients (API) and drug product materials.

Pharmaceutical 95

Pharmaceutical Manufacturing Food Electronics 95