Precision in Pharmaceutical Analysis: Resmetirom Impurity Standards from AquigenBio - aquigenbio/blog GitHub Wiki

Resmetirom is a breakthrough thyroid hormone receptor-β agonist, currently under investigation for the treatment of nonalcoholic steatohepatitis (NASH). The successful development, validation, and filing of Resmetirom-based therapies require precision in impurity profiling — a critical cornerstone of global regulatory acceptance.

Why Choose AquigenBio’s Resmetirom Impurities?

  • High-Purity Reference Standards: Each impurity is synthesized and purified to >95% purity, with robust documentation including HPLC, MS, and NMR characterization data for your quality assurance.

  • Regulatory Readiness: All products are crafted to support compliance with FDA, EMA, and ICH guidelines. They are essential for AMV, ANDA, DMF, and NDA submissions, helping you meet impurity identification thresholds and avoid regulatory bottlenecks.

  • Quick Turnaround & Reliable Supply: AquigenBio’s impurities are available for immediate dispatch, minimizing delays in analytical projects and regulatory filings.

  • Custom Synthesis & Isotopic Standards: Whether you need unique impurities or stable isotope-labeled standards for cutting-edge LC-MS assays, AquigenBio offers custom synthesis on request — ensuring your analytical needs are fully met.

  • Certificate of Analysis & Traceability: Each batch is accompanied by a comprehensive Certificate of Analysis (CoA), meeting regulatory expectations and supporting audits.

Key Applications

  • Analytical method development & validation
  • Impurity profiling and quantification
  • Quality control for batch release
  • Stability studies and toxicological assessments
  • Regulatory submissions and dossier filings

Featured Impurities & Standards

AquigenBio’s range includes:

  • Resmetirom Impurity 10 (CAS 1581304–50–8): Enables method validation, impurity identification, and QC.

  • Isotopically labeled Resmetirom standards (e.g. 13C3 15N): Ideal for advanced bioanalytical LC-MS assays, supporting robust pharmacokinetic studies.

  • Additional Resmetirom impurities for comprehensive profiling — all supplied with in-depth analytical data.

Empower Your Research and Compliance Journey

With the global pharma landscape shifting rapidly toward metabolic and liver disease solutions, access to validated impurity standards is non-negotiable. AquigenBio delivers the foundation you need for regulatory confidence, analytical precision, and accelerated product development.

Contact AquigenBio Today to request a quote or discuss custom impurity solutions. Benefit from industry-leading quality, rapid fulfillment, and expert support — all designed to maximize your research impact and unlock successful regulatory filings.