Extractables & Leachables Testing
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.
- 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
- 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
- TGA, DCS
- X-ray fluorescence analysis
- ASE (accelerated solvent extraction)
2015On CPHI since
2015On CPHI since
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SGS resources (6)
News SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatmentThe CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.
With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV).
SGS launches OneVision, a global digitalization initiative to standardize record-keeping procedures across all Life Sciences’ testing laboratories.
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane. This renders them inert to many familiar antibiotics, including the beta-lactams, whose activity relies on cell wall disruption. Many different mycoplasma are pathogenic in humans, and they are also commonly found as contaminants in cell cultures. Although the contamination does not create turbidity, factors such as cell line growth rates and viral vaccine production can be adversely affected. This clearly poses a problem for processes that involve cell culture, and thus, being able to detect them is important.
SGS has significantly increased its capabilities to undertake extractables and leachables (E&L) testing at its Shanghai, China, laboratory.
SGS has celebrated the official opening of the Biologics, Viral Vaccine, Gene and Cell Therapy Testing facility expansion in Glasgow, UK in May. The newly extended state-of-the-art facility now doubles the total floor space from 1,200 m2 to 2,400 m2.
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