CLS is having expertise to Design, develop and execute the E&L studies for pharmaceutical packaging materials/Container Closure Systems (CCS) and Medical Devices according to the various regulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters), EMA, PQRI, ICH, ISO 10993, and other specific standards/customer requirements.
Analytical Techniques
Organic impurities analysis by GC, GC-MS/MS, HPLC and LC-MS/MS
Elemental analysis by ICPMS
Functional identifications by FTIR and UV/Vis Spectroscopy
E&L Capabilities
- Preparation of Extractables and leachables study design including Analytical Evaluation Threshold (AET)
- Extractables and leachables evaluations
- Ensuring the compatibility of drug & container/closure
- Method Development & Validation for Leachable Studies
- Ensuring safety relative to Packaging Adulterants
- Toxicological Risk Assessment and Packaging material Safety analysis
- Label Migration Studies or Ink Migration Studies
- Controlled Extraction Studies for Raw Material control
