Sample interview questions: Can you describe your experience with the analysis and quantification of extractables and leachables from pharmaceutical packaging materials?
Sample answer:
- Conducted comprehensive analysis of extractables and leachables from various pharmaceutical packaging materials, including plastics, glass, and elastomers, to ensure product safety and compliance with regulatory guidelines.
- Employed a range of analytical techniques, including liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma-mass spectrometry (ICP-MS), and atomic absorption spectroscopy (AAS), to identify and quantify extractables and leachables.
- Developed and implemented robust analytical methods for the extraction, isolation, and quantification of extractables and leachables from complex packaging materials, ensuring accurate and reliable results.
- Evaluated the potential migration of extractables and leachables from packaging materials into pharmaceutical products under various storage conditions, using accelerated aging studies and real-time stability testing.
- Assessed the impact of extractables and leachables on the safety and efficacy of pharmaceutical products, including potential interactions with drug substances and excipients.
- Provided expert guidance an… Read full answer
Source: https://hireabo.com/job/5_2_16/Pharmaceutical%20Chemist