Detection of low-level PTFE contamination: An application of solid-state NMR to structure elucidation in the pharmaceutical industry

Spontaneous Carbonate Formation in an Amorphous, Amine-Rich, Polymeric Drug Substance: Sevelamer HCl Product Quality

“…Solid‐state NMR was chosen for these studies because of its ability to characterize both amorphous and crystalline solids, including changes in salt forms, as well as its ability to look at molecular mobility and phase separation 10. It previously has been demonstrated as a useful tool for detecting an insoluble impurity within a pharmaceutical preparation,11 and herein it proved very useful in characterizing an insoluble drug substance. One of the main strengths of SSNMR is its ability to selectively analyze drug substance in the presence of excipients 10,12.…”

Recent Advances in Solid-State Analysis of Pharmaceuticals

“…Full characterization to determine structural and dynamical properties of the drug as well as interactions between the drug and the silica substrate were successfully carried out. Active ingredients aside, 19 F NMR has also been used to quantify polytetrafluoroethylene (PTFE) contamination in drugs that could potentially arise from pharmaceutical manufacturing or testing equipments [14]. The study demonstrated the superb sensitivity of the technique for the detection of fluoropolymer contaminants in drugs at levels as low as 0.02%.…”

Carbon–Deuterium Rotational-Echo Double-Resonance NMR Spectroscopy of Lyophilized Aspartame Formulations

“…[15][16][17][18][19][20][21] Specifically, several high-resolution magic-angle spinning (MAS) NMR experiments can be used to measure internuclear distances within a molecule, and these distances may be even measured in a formulation containing less than 10% of the active ingredient. Distances between nuclei can be obtained by MAS NMR, by measuring the dipolar interaction between coupled spin pairs.…”