?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.