The purpose of this whitepaper is to provide comprehensive guidance on determining the appropriate alcohol/water proportion for simulating solvents used in controlled extraction studies relevant to drug products. These studies are essential for drug products packaged in plastic container systems, administered via plastic devices, or manufactured using systems that consist of plastic components. The whitepaper offers scientific guidance and includes a case study that examines the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
Readers will gain a thorough understanding of the various factors influencing the selection of the appropriate alcohol/water proportion for their specific applications. The document emphasizes the critical role of solvent polarity and its impact on extractables levels, offering practical insights into optimizing extraction studies to ensure accurate and reliable results.
By grasping the scientific principles behind selecting the right alcohol/water proportion, professionals involved in drug product development, quality assurance, and regulatory compliance can significantly improve their controlled extraction studies. This knowledge will aid them in ensuring that their products meet stringent safety and performance standards, thereby enhancing patient safety and product efficacy.
The whitepaper serves as an invaluable resource for those seeking to optimize their extraction protocols, providing detailed guidance on the selection process and the scientific rationale behind it. It underscores the importance of precise solvent selection in the development of safe and effective drug products, ultimately contributing to the advancement of pharmaceutical quality and safety.