Description

Venlafaxine n-Dimer is a high-purity pharmaceutical intermediate and reference standard of significant importance in modern drug development and quality control. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by serving as a key marker for process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the synthesis, purification, and rigorous testing of Venlafaxine and related antidepressant medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of process impurities in Venlafaxine API batches.
• Critical component in analytical method development and validation (HPLC, LC-MS) for regulatory compliance.
• Essential raw material in research and development of synthetic pathways and purification processes for antidepressants.
• Used in stability studies to monitor degradation profiles and establish shelf-life specifications.
• Serves as a calibration standard in quality control laboratories to ensure batch-to-batch consistency.
• Important for regulatory submissions (e.g., FDA, EMA) to demonstrate control over potential genotoxic impurities.

Basic Information

Product Name	Venlafaxine n-Dimer
CAS No.	1187545-61-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Venlafaxine Dimer; Venlafaxine Related Compound; Venlafaxine Impurity; 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol Dimer; Effexor Dimer; (R/S)-1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol Dimer
EINECS	Contact for details

Quality Control

Our Venlafaxine n-Dimer is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

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 under anhydrous conditions. 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
Water Content (KF)	≤ 1.0%

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