Comprehensive analysis of packaging system components for pharmaceutical safety
Pharmaceutical manufacturers need to determine the extractables and leachables profile of their packaging system components. This is to ensure that the product quality and the safety of the patients are maintained.
Our team of experts can provide you with analytical expertise to determine the most appropriate safety thresholds, extraction and analysis techniques.
We offer comprehensive extraction techniques designed to simulate various conditions that packaging materials may encounter during their lifecycle:
High-temperature extraction using boiling solvents to identify high-boiling point compounds.
Continuous extraction method for thorough compound recovery from solid materials.
Ultrasonic-assisted extraction for gentle and efficient compound isolation.
Our analytical techniques include semi-quantitative screening by LC/MS, GC/MS, LC/UV, providing comprehensive coverage of both volatile and non-volatile compounds.
Use of GC/MS instrumentation with direct injection sample introduction and electron impact ionization for comprehensive volatile compound analysis.
Use of GC/MS instrumentation with headspace sample introduction and electron impact ionization for non-destructive volatile compound analysis.
For extractables compounds detected by GC/MS analysis, we utilize NIST2011 database to assist in identification, providing reliable compound characterization and structural information.
Analysis using LC/HRMS, HPLC/UPLC MS (electrospray and atmospheric pressure chemical ionization) and LC/UV-vis for comprehensive non-volatile compound analysis.
Specific compound workflow identification by means of LC-HRMS analysis and Compound Discoverer software for automated compound identification and characterization.
Ensure product quality and patient safety through comprehensive extractables and leachables analysis.
Meet global regulatory requirements with our comprehensive analytical approach.
Identify and assess potential risks early in the development process.
Contact our extractables and leachables team to discuss your packaging analysis needs and safety requirements.