Description

o-Desmethyl Venlafaxine Cyclic Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of a key process-related impurity in the synthesis of Venlafaxine and its active metabolite, O-desmethylvenlafaxine. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent international guidelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for method development and validation in HPLC, UPLC, and LC-MS analyses.
• Quality Control and Assurance (QC/QA): Used as a primary standard for establishing acceptance criteria and monitoring batch-to-batch consistency of Venlafaxine Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Regulatory Submission and Compliance: Critical for preparing impurity identification reports required by regulatory bodies like the FDA, EMA, and ICH to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2) guidelines.
• Process Chemistry Optimization: Helps synthetic chemists identify and mitigate the formation of this cyclic impurity during the manufacturing process, improving yield and purity.
• Academic and Contract Research: Used in universities and CROs (Contract Research Organizations) for pharmacological studies and impurity synthesis research related to serotonin-norepinephrine reuptake inhibitors (SNRIs).

Basic Information

Product Name	o-Desmethyl Venlafaxine Cyclic Impurity
CAS No.	1346601-55-5
Molecular Formula	C16H25NO2
Molecular Weight	263.38 g/mol
Synonyms	1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol; O-Desmethylvenlafaxine Cyclic Impurity; Venlafaxine Cyclic Impurity; ODV Cyclic Impurity; Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-; UNII-9F8S6A6D4C; 9F8S6A6D4C
EINECS	Contact for details

Quality Control

Every batch of o-Desmethyl Venlafaxine Cyclic Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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 guidelines
Water Content (KF)	≤ 0.5%

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