Description

Venlafaxine Impurity 13 is a high-purity reference standard used in the pharmaceutical development and quality control of the antidepressant Venlafaxine. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of this specific process-related impurity. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Venlafaxine Impurity 13 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Critical component in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Venlafaxine.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation over time.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Venlafaxine to minimize the formation of this impurity.

Basic Information

Product Name	Venlafaxine Impurity 13
CAS No.	727728-51-0
Molecular Formula	C17H27NO2
Molecular Weight	277.40 g/mol
Synonyms	1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol; O-Desmethylvenlafaxine Impurity; Venlafaxine Related Compound 13; Desvenlafaxine Impurity; Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-; ODV Impurity
EINECS	Contact for details

Quality Control

Every batch of Venlafaxine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming its suitability for use as a reference standard.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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