Category
Tetrabenazine
CAS Number
NA
Molecular Formula
C₁₉H₂₇NO₃
Molecular Weight
317.42 g/mol
Synonym

9,10-dimethoxy-3-isobutyl-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one

Keywords
Pharmaceutical Standards
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.

Tetrabenazine Related Compound 3 is a specified impurity or degradation product associated with the drug tetrabenazine, which is used in the treatment of movement disorders such as Huntington’s disease–related chorea. This compound is typically formed during the synthesis process or through chemical breakdown of the active pharmaceutical ingredient under certain storage or stress conditions. In pharmaceutical quality control, Related Compound 3 is monitored and quantified because impurities can affect the purity, safety, and efficacy of the final drug product. Regulatory guidelines require that its level remains within strict limits, usually determined using analytical methods like HPLC (High-Performance Liquid Chromatography).