Qi, Li; Liu, Jian; Ronk, Michael; Gallegos, Alejandra; Fujimori, Kiyoshi; Luo, Yanxin; Li, Kim; Lee, Hans; Nashed-Samuel, Yasser published the artcile< A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products>, Recommanded Product: 2,2′-(Tridecylazanediyl)diethanol, the main research area is rubber stoppered glass vial extractable leachable biotechnol; Extractables; Glass vials; Holistic approach; ICH Q3D; Leachables; Rubber stoppers; Toxicology.
Rubber stoppered glass vial systems are widely used as primary containers for storing and delivering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biol. drug product quality and patient safety from rubber stoppered glass vial systems requires implementation of an extractable and leachable evaluation program based on material understanding, risk assessment, literature review, and a comprehensive scientifically sound anal. testing methodol. The extractable and leachable study design consisted of twelve drug products filled in twelve different size glass vials capped with laminated and nonlaminated rubber stoppers made from three different rubber formulations. Design of the model solvents was successful as they had little to no anal. interference and mimicked the formulation conditions and generated representative extractables capable of predicting leachables. The extraction conditions of time and temperature were appropriate as not to degrade the test materials or the extractable compounds, and yet generated significant quantities for identification of the extractable compounds with confidence. The extractables testing results were capable of predicting the leachable profiles of the twelve drug products. In each case, the leachable profile was a subset of the extractable profile. The organic and elemental impurities of the leachable profiles of drug products were the end-to-end verification of the quality of the glass vials, rubber stoppers and drug product lifecycles. Overall, the holistic approach was fully successful in the qualification of different vial systems as primary containers and delivery systems for different biotherapeutic products to ensure product quality and patient safety.
Journal of Pharmaceutical Sciences (Philadelphia, PA, United States) published new progress about Bioavailability. 18312-57-7 belongs to class ethers-buliding-blocks, and the molecular formula is C17H37NO2, Recommanded Product: 2,2′-(Tridecylazanediyl)diethanol.
Referemce:
Ether – Wikipedia,
Ether | (C2H5)2O – PubChem