Table 2.
Technologies for testing poor quality medicines
| Tests useable in field | Detects |
|---|---|
| Visual inspection of package and product | Wrong package, color, size, shape, and spelling |
| Alternative light sources | Wrong color of ink, holograms, packaging, excipients in pills (wavelengths in the visible (350–700 nm) and nonvisible (> 700 nm) electromagnetic spectrum |
| Colorimetry | Wrong kind and/or amounts of API |
| Simplified disintegration tests | Disintegration, as marker for bioavailability |
| “Minilab” | Compendium of thin-layer chromatography and simplified disintegration tests |
| Raman spectroscopy (portable, dispersive) | Active ingredients identity by radiation scattering and database matching |
| NIR spectroscopy (portable, dispersive) | Active ingredients identity by radiation reflection/absorption and database matching |
| Tests requiring central laboratory | Detects |
| GC | Quantify volatile organic residual solvents, link to manufacturer |
| HPLC | Quantify known active ingredients and impurities |
| NMR spectroscopy | Identify and verify identity of active ingredients, excipients; enhanced structural information |
| Raman spectroscopy (Fourier transform) | Identify active ingredients, excipients; relative concentrations, coating composition, spatially-resolved information through microscopy |
| Dissolution tests | Index of bioavailability |
| Ambient (direct) MS | Screen identity and semiquantitation of active ingredients, excipients, analogs, undeclared compounds, impurities |
| GC–MS | Confirm identity of volatile ingredients and residual solvents, contaminants, undeclared compounds, and impurities with higher selectivity |
| LC–MS and tandem MS/MS | Quantify active ingredients, excipients; identify wrong active ingredients with higher selectivity |
API = active pharmaceutical ingredient; GC = gas chromatography; HPLC = high-performance liquid chromatography; LC = liquid chromatography; MS = mass spectrometry; NIR = near infrared; NMR = nuclear magnetic resonance.