The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as, primary and secondary container closures are potential vectors for chemical contaminants. Monomers and polymer additives such as antioxidants, plasticisers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. SGS provides a complete service for testing Extractables in container materials and Leachables in final products. These tests are conducted in cGMP compliant laboratories using technologies that detect ultra trace levels.
Services
- Test strategy planning and data evaluation based on the available information
- Development of a tailored study design for Extractables and Leachables
- Extractables profiling (inorganic and organic extractables)
- Sequential extractions and alternative extraction techniques for isolating Extractables in container materials
- Characterization of Extractables by chromatographic and spectroscopic investigations
- Determination of the Analytical Estimation Threshold (AET)
- Calculation of the Qualification Threshold based on Safety Concern Threshold (SCT)
- Method development and validation of potential Leachables in pharmaceutical products
- Performing of Leachables studies on pharmaceutical products
- Reporting and evaluation of results within the current guidelines
Technologies
- HPLC-MS/MS, HPLC Q-Tof, HPLC-UV, DAD
- HS-GC, HS-GC-MS
- GC (FID, ECD, FID-NP), GC-MS
- GC-TEA (nitrosamines)
- ICP-OES, ICP-MS, AAS, IR
- FTIR
- TGA, DCS
- X-ray fluorescence analysis
- ASE (accelerated solvent extraction)
- Soxhlet
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