A pharmaceutical company sought comprehensive extractable and leachable testing for a new oral solution product’s packaging components, including PET bottles, adaptors, and syringes, to meet increasing FDA requirements. The project involved complex challenges in simulating real-world conditions through controlled extractions using various solvents and implementing multiple analytical methods. 

Sannova developed a detailed protocol with specific extraction conditions and analytical techniques, utilizing LC/MS/MS, GC-HSFID/MS, GC-FID/MS, and ICP/MS to quantify impurities. Testing included analyses at different pH levels, accelerated stability conditions over six months, and identification of impurities through library and reference standard matching. Through transparent scientist-to-scientist collaboration and robust methodology, the study successfully generated reliable data for regulatory submission and product safety assessment.