Description

Tetrabenazine Related Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of the active pharmaceutical ingredient Tetrabenazine, a medication used to treat hyperkinetic movement disorders. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification in Tetrabenazine API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, GC) for accurate quantification of related substances.
• Quality Control and Release Testing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies to monitor impurity formation in drug products under various storage conditions.
• Regulatory Submissions as a characterized impurity reference standard for ANDA, NDA, and DMF filings.
• Research and Development of Tetrabenazine synthesis pathways and degradation chemistry.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Tetrabenazine Related Impurity 1
CAS No.	99672-64-7
Molecular Formula	C19H27NO3
Molecular Weight	317.42 g/mol
Synonyms	9,10-Dimethoxy-1,3,4,6,7,11b-hexahydro-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one; Tetrabenazine Impurity 1; TBZ Impurity 1; Nitoman Impurity; Xenazine Impurity; Dihydrotetrabenazine Impurity; RO 1-9569 Impurity
EINECS	Contact for details

Quality Control

Our Tetrabenazine Related Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (ICH Q3C), and structural confirmation (NMR, MS, IR) to ensure identity and purity. Certificates of Analysis (COA) detailing all test results and traceable to reference standards are available upon request.

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); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

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%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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