Leaching into drug products of chemical compounds coming from packaging polymeric material, adhesives, inks or its degradation products originated during its normal storage conditions poses a potential risk to the patient due to toxicity of the leachables or negative impact on the efficacy of the API.
Special concern of leachables must be emphasized on biologics drug products due to potentially deleterious effects on proteins such as aggregation, unfolding, etc.
A comprehensive study of Leachables in a drug product starts with the investigation of Extractable chemical species in the packaging materials prone to be leached to the drug.
After a detailed technical agreement with the sponsor of the Extractables study and backing on current guidelines (PQRI, USP1663, etc.) we can perform different designs of controlled extraction and simulated-use extraction studies.
Volatile, semi-volatile, non-volatile, and inorganic extractables are then identified by our organic chemistry scientists using an array of hyphenated mass spectrometric instruments and specific libraries and software tools: HS-GC-MS, GC-MS, HPLC-DAD-QTOF, ICP-MS, Preparative HPLC, FT-IR, NMR.
The challenge of developing highly sensitive quantitative analytical methods for the analysis of the Extractable compounds selected for the Leachables study is addressed with the support of high-end instruments of HPLC-MS/MS, HS-GC-MS/MS, and GC-MS/MS.