Description

Tetrabenazine Related Impurity 2 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of Tetrabenazine, a medication used to treat hyperkinetic movement disorders, by enabling accurate identification and quantification of this specific impurity. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working in the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Tetrabenazine Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with strict pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Tetrabenazine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Tetrabenazine Related Impurity 2
CAS No.	1381929-92-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tetrabenazine Impurity 2; Tetrabenazine Related Compound 2; Tetrabenazine Specified Impurity 2; Tetrabenazine Process Impurity; Tetrabenazine Degradant; (1R,3R,4S,11bS)-1,3,4,6,7,11b-Hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one Impurity; Xenazine Impurity 2; Nitoman Impurity 2
EINECS	Contact for details

Quality Control

Our Tetrabenazine Related Impurity 2 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes rigorous analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity assessment by chromatographic techniques (HPLC, GC). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (ICH, USP).

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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