This application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.
Diving Deep into Carrier-Based Formulation and Process Optimization
December 23rd 2024Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations
Molecular Properties of PROTACs and the Relationship to Formulation Design
December 20th 2024Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.
Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.