Leachables from Container Closure systems can impact the impurity profile of your drug product. Submissions for orally inhaled nasal drug products (OINDP) and injectable solutions generally include a description of potential extractables with a safety assessment and a determination of observed leachable compounds. ABC Laboratories has conducted studies that provided this data for many drug product types. Two inhalation products containing Extractables and Leachables data generated at ABC Laboratories were approved first round. All OINDP study protocols are based on recommendations found in the PQRI best practices paper.
Our experience includes canisters, LDPE vials, valves from various manufacturers, DPI, and glass syringes with well known stopper and vial cap systems.
Our state-of-the-art equipment, including UPLC TOF and ion Trap mass spectrometers can provide the high end identification horsepower required for this type of trace analysis.
Let our experienced regulatory advisors and staff scientists design your next E&L program.