Extractable and Leachables test
Evaluating the extraction and dissolution of biological/pharmaceutical products is an important step in drug development. Processing equipment and the closure of primary and secondary containers may cause chemical contamination.
Monomers and polymeric additives, such as antioxidants, plasticizers, stabilizers, colorants, metal catalysts, and other hazardous chemicals may infiltrate the product in the storage environment. SGS provides a comprehensive service, testing container material extraction, and final product dissolution. These tests are performed in cGMP-compliant laboratories and are performed using techniques that can determine additional trace levels.
- Extraction test, dissolution test
- Test strategy planning and data evaluation based on existing information
- Develop custom research designs for extraction and dissolution
- Extraction analysis (inorganic and organic extraction)
- Sequential extraction and alternative extraction technology to separate the extract from the container material
- Chromatographic and spectroscopic investigations to trace the extract
- Determine Analytical Estimate Threshold (AET)
- Calculate the eligibility threshold based on the Security Concern Threshold (SCT)
- Method development and verification of potential leachables in pharmaceutical products
- Within the scope of the current guidelines, carry out dissolution research reports of pharmaceutical products and evaluate the results.
- Extraction and dissolution testing and evaluation technology
- 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
- Accelerated Solvent Extraction (ASE)
- Soxhlet
Contact SGS now to find out how we can help you with extraction and dissolution testing.