If you have an unknown substance we can quickly and confidently help identify the material. We have expertise in analysis of:
- Failures
- OOS
- Contaminants
Manufacturers need to know the source of contamination when an unknown material is found in a pharmaceutical product. We have extensive expertise in identification of foreign items in raw materials through finished drug product. With not only expert analytical chemists but also a complete set of analytical tools at our disposal (including state-of-the-art spectroscopic and optical systems), we can quickly and confidently identify the unwanted substances in your samples.
Pharmaceutical contamination testing and identification projects at Triclinic Labs involve off-color investigations as well as foreign materials in a product. Sources of contaminants include the environment, improper storage of the product, poor quality raw materials, items introduced during manufacturing including those from an undetected change in the process (e.g. polymorphic conversion), and unexpected sources. We work quickly and closely with you to determine the source of contamination and develop a corrective action program.
| Contaminant Analysis Techniques Available |
| RAMAN Chemical imaging and micro and macro product mapping |
| Scanning Electron Microscopy & CryoSEM (hydrated samples) |
| SEM/Electron Dispersive X-Ray (Micro Elemental Analysis) |
| Optical Microscopy (Still and dynamic image capturing) |
| FT-IR with ATR, diffuse reflectance, transmission, gas cell, spectral libraries |
| Mass Spectrometry (GC/MS, LC/MS, LC/MS/MS and MALDI) |
Figure 1. Analysis of a contaminant found in raw material. Optical microscopy and subsequent spectral analysis confirms the material is cottton fiber. False color SEM. For more information on microscopy and imaging please click here.
For more information please contact us. See Below for details.