Extractable and Leachable Studies
Management of leachables is important to pharmaceutical and biotechnology/biologic product manufacturers and regulatory authorities because certain leachables above specific concentrations can present patient safety concerns and/or compatibility issues for drug product formulations.
Regulatory guidelines, requirements, and various best practice recommendations state that the definitive assessment of the potential impact of contact between a packaging/delivery system and a final dosage form involves testing the final drug for leachables.
Services provided by IAS under Extractable and Leachable Studies:
- Identification and quantification of drug product leachables to the extent practicable and within certain defined analytical threshold parameters
- Selection of Container Closure System (CCS) for dosage forms
- Migration study for impurities possibly migrating from Ink/Gum and other components
- Extractable and Leachable Study on Rubber stoppers, Gaskets & O-rings, Containers (HDPE, LDPE, PP), plastic bags, glass vials, syringes, tubing & filter, injectable bags/vials, films, blister packs, laminated tubes, etc.
- Development and Validation of identified leachables as per the requirement of customers
Techniques used for Extractable and Leachable Studies:
- GC-HS-MS (Make:- Shimadzu) for the analysis of semi-volatile and volatile components
- LCMS (Make:- Shimadzu) for the analysis of non-volatile components
- ICPMS (Make:- Thermo) for analysis of elemental impurities