We provide comprehensive testing services for detection and quantification of extractables and leachables in Closed Container Systems (CCS) from immediate container fabrication components, migratory materials from labeling & secondary packaging, reaction products between formulation and CCS and processing equipments. These tests are conducted by using technologies that detect ultra trace levels at acceptable LOD & LOQ. Our services include.
- Designing tailored test strategy and data evaluation based on the available information to meet the Compendial requirements [like USP <661>, <1151>, <601>] and other guidelines.
- Method development and validation of potential leachables in pharmaceutical and food products.
- Established methodology to analyze solutions by using LS-MS, LC-MS/MS, GC-MS, GC-MS/MS, LC-UV, ICP-MS and FTIR. In addition LC Q-TOF/MS is utilized for accurate mass detection.
- Profiling of inorganic and organic extractables
- Sequential extractions and alternative extraction techniques for isolating extractables in container materials
- Characterization of extractables by chromatographic and spectroscopic methods
- Determination of the Analytical Estimation Threshold (AET)
- Calculation of the qualification threshold based on Safety Concern Threshold (SCT)
- Report detailing the results of Extractables and Leachables studies include mass spectra of tentatively identified peak, comparison of spectra from commercially available and in-house data base, evaluation and interpretation of results.