Description

o-Desmethyl Venlafaxine Cyclic Impurity-D5 is a deuterium-labeled internal standard critical for the accurate quantification of a key process-related impurity in the synthesis of the antidepressant Venlafaxine. This high-purity reference material is essential for ensuring the safety and efficacy of the final Active Pharmaceutical Ingredient (API) by enabling precise analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the quantitative analysis of o-Desmethyl Venlafaxine Cyclic Impurity in Venlafaxine API and finished dosage forms via LC-MS/MS and HPLC.
• Method Development & Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control impurity levels, ensuring every batch meets specified purity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity profiles over the drug product's shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Research & Development: Supports impurity fate and tolerance studies during process chemistry R&D and scale-up activities.

Basic Information

Item	Detail
Product Name	o-Desmethyl Venlafaxine Cyclic Impurity-D5
CAS No.	1346598-83-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol-d5; O-Desmethylvenlafaxine Cyclic Impurity D5; Cyclic Impurity of O-Desmethylvenlafaxine-d5; Deuterated Venlafaxine Impurity Standard; Venlafaxine Related Compound D5; ODV Cyclic Impurity D5
EINECS	Contact for details

Quality Control

Every batch of o-Desmethyl Venlafaxine Cyclic Impurity-D5 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data for identity, purity (by HPLC), isotopic enrichment, and specified impurities. We support compliance with ICH, USP, and EP guidelines for reference standards. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. The container should be opened only under anhydrous conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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