Why Phosphoramidite Impurity Standards Are Non-Negotiable for Oligonucleotide Therapeutic Safety

Webinar

Phosphoramidite chemistry remains the cornerstone of solid-phase oligonucleotide synthesis, and the purity of the nucleoside phosphoramidite monomers used is critical to the safety and efficacy of the resulting therapeutic or diagnostic products. As regulatory frameworks, most notably the United States Pharmacopeia (USP), increasingly define critical and reactive impurities for oligonucleotide starting materials, the demand for well-characterized, analytical reference standards has grown substantially, with the goal to confirm purity of the  active pharmaceutical ingredients (APIs).

During the webinar, you will:

• Discover the analytical challenges in characterizing nucleoside phosphoramidite impurity standards and how they impact oligonucleotide API purity assessment.
• Understand the rationale for selecting specific impurity targets and the criteria for fit-for-purpose analytical reference standards.
• Explore proper handling, storage, and certification considerations to maintain RM integrity and traceability.
• Learn how this reference materials support regulatory expectations (e.g., USP) and quality control in the oligonucleotide therapeutics industry.