Description

Tetrabenazine Dehydro Impurity is a key chemical reference standard used in the analytical profiling and quality control of Tetrabenazine, an important pharmaceutical active ingredient. This impurity is critical for ensuring the purity, safety, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, validation, and batch release of Tetrabenazine-based medications.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the dehydro impurity in Tetrabenazine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control laboratories to confirm that Tetrabenazine API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Tetrabenazine formulations.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in synthetic chemistry R&D to study the formation pathways and to develop purification processes that minimize this impurity.

Basic Information

Product Name	Tetrabenazine Dehydro Impurity
CAS No.	100322-43-8
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	Dehydrotetrabenazine; Tetrabenazine Impurity D; (3R,11bR)-9,10-Dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1H-benzo[a]quinolizin-1-one; 1,3,4,6,7,11b-Hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one; Tetrabenazine Related Compound D; Tetrabenazine USP Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Tetrabenazine Dehydro Impurity is manufactured and analyzed under strict quality management systems. It undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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