Category
Tetrabenazine
CAS Number
2624055-86-1
Molecular Formula
C₁₉H₂₄NO₂
Molecular Weight
298.4 g/mol
Synonym

3-Isobutyl-9,10-dimethoxy-6,7-dihydropyrido[2,1-a]isoquinolin-5-ium; Valbenazine Impurity 4 ; Tetrabenazine Impurity

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 Analog Impurity refers to a structurally similar compound that is unintentionally formed during the synthesis, processing, or degradation of tetrabenazine. It has a molecular structure closely related to tetrabenazine but differs slightly due to variations in functional groups or stereochemistry. Because of this similarity, it is classified as an “analog impurity” in pharmaceutical quality control. Such impurities are carefully monitored using analytical techniques like HPLC or LC–MS, as they may affect the drug’s purity, stability, and safety profile. Regulatory standards require that analog impurities remain within defined limits to ensure the final medicinal product is safe and effective for patient use.