Description

Venlafaxine n-Oxide Impurity is a specified degradation product and metabolite of the antidepressant Venlafaxine, identified by CAS No. 1021933-95-8. This compound is critically important for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and impurity profiling. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories engaged in the production and validation of Venlafaxine hydrochloride API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Venlafaxine n-Oxide in active pharmaceutical ingredient (API) and drug product testing.
• Impurity Profiling and Control: Essential for establishing and validating impurity limits in accordance with ICH Q3A(R2) and Q3B(R2) guidelines for new drug substances and products.
• Stability Indicating Method Development: Employed in the development and validation of HPLC/LC-MS methods to monitor the formation of this oxidative degradation product during stability studies.
• Metabolite Studies: Used in preclinical and clinical research to understand the metabolic pathway and pharmacokinetics of Venlafaxine.
• Quality Assurance & Control (QA/QC): Serves as a system suitability standard and for routine batch release testing of Venlafaxine API to ensure compliance with pharmacopeial specifications.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) that requires characterization and qualification of known impurities.

Basic Information

Product Name	Venlafaxine n-Oxide Impurity
CAS No.	1021933-95-8
Molecular Formula	C17H27NO3
Molecular Weight	293.41 g/mol
Synonyms	Venlafaxine N-Oxide; Venlafaxine Impurity N-Oxide; 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol N-Oxide; (±)-1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol N-Oxide; Venlafaxine Related Compound N-Oxide; Venlafaxine Metabolite N-Oxide; UNII-6V2F5P6D6I; Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, N-oxide
EINECS	Contact for details

Quality Control

Our Venlafaxine n-Oxide Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for impurity standards.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.