Category
Tafamidis
CAS Number
NA
Molecular Formula
C₁₄H₁₀Cl₂N₂O₄
Molecular Weight
341.14 g/mol
Synonym

4-(2-Amino-3,5-dichlorobenzamido)-3-hydroxybenzoic acid

Keywords
Pharmaceutical Standards
Metabolites.
Impurities
slide.1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Tafamidis Impurity 24 is a process-related impurity linked to the synthesis or degradation of the drug Tafamidis, used in the treatment of transthyretin amyloidosis. It is generally considered a trace by-product formed during specific reaction steps, intermediate transformations, or under stress conditions such as heat, light, or oxidation. This impurity is routinely monitored using analytical methods like HPLC or LC–MS to ensure the final pharmaceutical product meets strict quality, safety, and regulatory standards.