European Pharmaceutical Review

SEPTEMBER 25, 2023

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. This has led to peptide mapping becoming the primary method for identity testing with these molecules.

Pharmaceutical 96

Pharmaceutical Manufacturing Food Electronics 96

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 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

Pharmaceutical Technology

MAY 10, 2023

Particle analysis on a micro-scale is a significant topic in several fields of application. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs). Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant.

Pharmaceutical 52

Pharmaceutical Specialization Electronics 52