Description

Valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, a key active pharmaceutical ingredient (API) in the treatment of tardive dyskinesia. Its precise mechanism of action makes it a critical component for pharmaceutical manufacturers developing targeted neurological therapies. This compound is essential for research institutions and pharmaceutical companies engaged in the development and production of advanced central nervous system (CNS) medications.

Application

• Pharmaceutical API: Primary active ingredient in FDA-approved treatments for tardive dyskinesia.
• Neurological Research: Critical reference standard and tool for studying VMAT2 inhibition and dopaminergic regulation.
• Drug Development: Used in the formulation and process development of extended-release capsules and other dosage forms.
• Analytical Standard: Serves as a high-purity standard for HPLC, LC-MS, and other analytical method development and validation.
• Preclinical Studies: Utilized in pharmacokinetic, pharmacodynamic, and toxicology studies for new CNS drug candidates.
• Generic Pharmaceutical Manufacturing: Sourced for the production of generic versions of branded tardive dyskinesia medications.

Basic Information

Product Name	Valbenazine
CAS No.	1025504-45-3
Molecular Formula	C24H38FN3O2
Molecular Weight	419.58 g/mol
Synonyms	NBI-98854; (+)-α-Dihydrotetrabenazine; (2R,3R,11bR)-1,3,4,6,7,11b-Hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl (2-amino-3-methylbutanoate) L-Valine ester of Dihydrotetrabenazine; Valbenazine ditosylate (salt form precursor)
EINECS	Contact for details

Quality Control

Our Valbenazine is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical development. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with ICH guidelines for impurities and can support documentation for regulatory filings (e.g., DMF).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.