Description

Rac N,n-Didesmethyl-o-Desmethyl Venlafaxine Glucuronide is a high-purity reference standard and pharmaceutical intermediate of significant analytical importance. This compound is critical for research and development, quality control, and regulatory compliance within the pharmaceutical industry. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and manufacturers involved in the development and production of antidepressant medications, specifically for metabolite identification and bioanalytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of venlafaxine metabolites in biological matrices and finished drug products.
• Metabolite Research & Identification: Essential for studying the metabolic pathways, pharmacokinetics, and pharmacodynamics of venlafaxine and related compounds.
• Bioanalytical Method Development: Used to develop, validate, and calibrate sensitive analytical methods such as LC-MS/MS and HPLC for clinical and preclinical studies.
• Impurity Profiling: Acts as a characterized impurity or degradation product standard to ensure drug substance and product purity per ICH guidelines.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., with the FDA, EMA) requiring full characterization of drug metabolites.
• Clinical Trial Material Analysis: Supports the accurate measurement of metabolite levels in patient samples during clinical trials for safety and efficacy evaluation.

Basic Information

Product Name	Rac N,n-Didesmethyl-o-Desmethyl Venlafaxine Glucuronide
CAS No.	1799830-07-1
Molecular Formula	C19H27NO8
Molecular Weight	397.42 g/mol
Synonyms	O-Desmethylvenlafaxine N,N-didesmethyl Glucuronide; Venlafaxine Metabolite Glucuronide (N,N-didesmethyl, O-desmethyl); 1-[4-[(1R*,2R*)-2-(Dimethylamino)-1-hydroxycyclohexyl]phenoxy]-β-D-glucopyranuronic acid; (R/S)-N,N-Didesmethyl-O-desmethylvenlafaxine β-D-Glucuronide; rac-DDVG; DDVG (racemic)
EINECS	Contact for details

Quality Control

Every batch of Rac N,n-Didesmethyl-o-Desmethyl Venlafaxine Glucuronide is manufactured under a strict quality management system and undergoes comprehensive analytical testing. We provide full traceability and Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, ensuring compliance with relevant pharmacopeial and ICH guidelines for reference standards. Our quality commitment supports your regulatory and research requirements with reliable, consistent material.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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