Leachable Stability Studies
According to the FDA’s published Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics, all new Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) submissions must submit adequate data to demonstrate the suitability of container systems for drug products. These include injection vials, parenteral packages, prefilled syringes and solid dose containers, and often involve studies of labels, liners and seals.
Maxxam has accumulated expertise in designing studies and developing methods to measure extractables in short term stress tests or leachables in long term stability studies. Studies rely on a diverse suite of analytical instrumentation including: ICPMS, LC-ICPMS, IC, HPLC, LC/MS and GC/MS.
