Category
Bazedoxifene
CAS Number
91444-54-1
Molecular Formula
C₁₅H₁₃NO₂
Molecular Weight
239.27 g/mol
Synonym

2-(4-Hydroxyphenyl)-3-methyl-1H-indol-5-ol; 1H-Indol-5-ol, 2-(4-hydroxyphenyl)-3-methyl; 2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol

Keywords
Miscellaneous compounds
Amines
Impurities
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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.

Bazedoxifene Dihydroxy Indole Impurity is a specific synthetic or degradation impurity that can appear in bazedoxifene or bazedoxifene acetate formulations. Chemically, it contains a dihydroxy-substituted indole moiety, which arises from side reactions during synthesis or storage. Regulatory standards require its content to be strictly controlled, as higher levels could compromise the drug’s purity, stability, and safety profile.