Description

Tetrabenazine Related Impurity 3 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 the active pharmaceutical ingredient Tetrabenazine by enabling accurate identification and quantification of process-related impurities. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require reliable reference materials for method validation, stability studies, and regulatory compliance.

Application

• Primary use as a certified reference standard for the analytical testing of Tetrabenazine API.
• Critical component in HPLC and LC-MS method development and validation for impurity profiling.
• Used in pharmaceutical quality control (QC) laboratories for routine batch release testing.
• Essential for stability studies to monitor impurity levels in drug products over time.
• Serves as a research-grade impurity for studying degradation pathways and synthesis optimization.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data.

Basic Information

Product Name	Tetrabenazine Related Impurity 3
CAS No.	19328-35-9
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	9,10-Dimethoxy-1,3,4,6,7,11b-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one; Tetrabenazine Impurity 3; TBZ Impurity 3; Nitoman Impurity 3; Xenazine Impurity 3; 1,3,4,6,7,11b-Hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one
EINECS	Contact for details

Quality Control

Every batch of Tetrabenazine Related Impurity 3 is manufactured and tested under strict quality management systems to ensure identity, purity, and consistency. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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