Description

Venlafaxine Impurity 5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in Venlafaxine hydrochloride active pharmaceutical ingredient (API) and its finished dosage forms. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories to ensure drug safety, efficacy, and compliance with stringent international pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Venlafaxine API and formulations.
• Analytical Research & Development: Used in HPLC, UPLC, and LC-MS studies to establish impurity profiles, degradation pathways, and stability-indicating methods.
• Regulatory Compliance & Filings: Essential for preparing impurity data packages required for regulatory submissions to agencies like the US FDA, EMA, and PMDA.
• Pharmacopeial Testing: Employed to verify compliance with impurity limits specified in monographs of USP, EP, BP, and other international pharmacopeias.
• Stability Studies: Used as a marker to track the formation of specific impurities during forced degradation and long-term stability studies of drug products.
• Contract Laboratory Services: A key material for third-party testing laboratories offering analytical and quality control services to the pharmaceutical industry.

Basic Information

Product Name	Venlafaxine Impurity 5
CAS No.	1346600-77-8
Molecular Formula	C17H27NO2
Molecular Weight	277.41 g/mol
Synonyms	Venlafaxine Related Compound 5; Venlafaxine EP Impurity 5; Venlafaxine USP Impurity 5; (1R,2R)-2-((Dimethylamino)methyl)-1-(4-methoxyphenyl)cyclohexanol; N,N-Dimethyl-2-((1R,2R)-1-hydroxy-2-(4-methoxyphenyl)cyclohexyl)methanamine; UNII-7V3Q8U4D4F
EINECS	Contact for details

Quality Control

Every batch of Venlafaxine Impurity 5 is manufactured under a quality management system and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our products are tested against stringent in-house specifications using advanced techniques including HPLC, GC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.