Category
Tetrabenazine
CAS Number
58-46-8
Molecular Formula
C₁₉H₂₇NO₃
Molecular Weight
317.42 g/mol
Synonym

((3RS,11bRS)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one); (3RS,11bRS )-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H -pyrido[2,1-a]isoquinolin-2-one; (+/-)-Tetrabenazine; Rubigen; (3R,11bR)-rel-1,3,4,6,7,11b-Hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one; 9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one; (SS,RR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-pyrido[2,1-a]isoquinolin-2-one

Keywords
Fine Chemicals
Pharmaceutical Standards
Heterocycles
Intermediates
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 standard refers to the official quality and purity requirements established in pharmacopoeias and regulatory guidelines to ensure the drug meets safety, identity, strength, and purity specifications. These standards define parameters such as assay limits, impurity profiling, dissolution behavior, and storage conditions so that the medication consistently delivers its intended therapeutic effect. They are used by manufacturers and quality control laboratories to verify that tetrabenazine formulations comply with accepted pharmaceutical norms before being approved for clinical use.