Description

Valbenazine Tosylate is a high-purity active pharmaceutical ingredient (API) and key intermediate in the synthesis of vesicular monoamine transporter 2 (VMAT2) inhibitors. This compound is critical for pharmaceutical manufacturers requiring reliable, consistent quality for advanced therapeutic development. It is primarily utilized by research institutions and pharmaceutical companies engaged in the development and production of treatments for neurological disorders.

Application

• Pharmaceutical API: Serves as the active pharmaceutical ingredient in the manufacture of finished dosage forms for VMAT2 inhibitor therapies.
• Neurological Disorder Research: A key compound in preclinical and clinical research targeting movement disorders such as tardive dyskinesia.
• Reference Standard: Used as a high-purity analytical reference standard in quality control laboratories for method development and validation.
• Process Development: Employed as a critical intermediate in the scale-up and optimization of synthetic routes for complex pharmaceutical molecules.
• Regulatory Submissions: Supplied as a well-characterized substance to support regulatory filings (e.g., DMF, CMC sections) with agencies like the FDA and EMA.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of clinical trial materials and commercial batches.

Basic Information

Product Name	Valbenazine Tosylate
CAS No.	1639208-54-0
Molecular Formula	C38H54N2O7S
Molecular Weight	682.91 g/mol
Synonyms	Valbenazine tosylate salt; (2R,3R,11bR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl (2R,3R)-2-[(1R)-1-hydroxy-3-methylbutyl]-3-(4-methylbenzoyl)amino]butanoate 4-methylbenzenesulfonate; NBI-98854 tosylate; Tetrabenazine analog tosylate; VMAT2 Inhibitor Valbenazine Tosylate
EINECS	Contact for details

Quality Control

Our Valbenazine Tosylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral methods for enantiomeric excess, and stringent control of residual solvents and impurities in accordance with ICH guidelines. A Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to ensure full traceability and compliance with cGMP standards for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Chiral Purity (HPLC)	≥99.0%
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%
Heavy Metals	≤20 ppm

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