3,6-Pyridazinedione, 1,2-dihydro-4-(1-methylethyl)-

‌Resmetirom Impurity (CAS 1903632-97-2)‌
Google Keywords: Resmetirom Impurity, CAS 1903632-97-2, Thyroid Receptor Agonist Impurities, NASH Drug Analysis, GMP Pharmaceutical Standards

🌟 ‌Product Overview‌

‌Resmetirom Impurity‌ (CAS 1903632-97-2) is a high-purity reference standard used for quality control in the synthesis of ‌Resmetirom‌, a novel thyroid hormone receptor-β agonist developed for treating non-alcoholic steatohepatitis (NASH) and metabolic disorders. This impurity ensures accurate identification and quantification during API development and regulatory submissions.

• ‌Primary Function‌: Critical for impurity profiling, stability studies, and batch release testing of Resmetirom.

• ‌Applications‌: NASH drug development, metabolic disorder therapies, and analytical method validation.

✅ ‌Key Advantages‌

🔹 ‌High Purity & Traceability‌ | ≥99.0% (HPLC/GC verified) | Complies with ICH Q3A/B guidelines.
🔹 ‌Regulatory Compliance‌ | Supports FDA/EMA filings with fully characterized structure (NMR, HRMS).
🔹 ‌Stability‌ | Long-term storage stability tested under controlled conditions.

🧪 ‌Applications‌

1. ‌NASH Drug Development‌: Essential for impurity control in Resmetirom API manufacturing.

2. ‌Analytical Testing‌: Used in HPLC/LC-MS method development and validation.

3. ‌Regulatory Compliance‌: Facilitates compliance with ICH impurity reporting thresholds.

📜 ‌Quality Assurance‌

• ‌Testing Methods‌: HPLC, GC, NMR, HRMS, and FTIR for structural confirmation and purity.

• ‌Standards‌: Meets USP <1086>, EP 10.0, and ISO 17025:2017 certified protocols.

📈 ‌Market Trends‌

The global ‌NASH treatment market‌ is projected to exceed ‌$21.4 billion by 2030‌ (CAGR 43.2%), driven by rising prevalence of metabolic liver diseases. Resmetirom impurities are pivotal in accelerating clinical trials and commercialization of next-generation therapies.

Ensure precision in NASH drug development with Resmetirom Impurity – unmatched purity, compliance, and reliability for critical quality control.