Description

n-Bis-Demethyl Tramadol is a key pharmaceutical intermediate and reference standard in the synthesis and analytical profiling of active pharmaceutical ingredients (APIs). This compound is of significant importance for research, development, and quality control within the pharmaceutical and fine chemical industries. It is primarily needed by manufacturers and analytical laboratories involved in the production and verification of tramadol-related compounds and novel analgesic formulations.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of tramadol and its novel analogs.
• Analytical Reference Standard: Used for method development, validation, and impurity profiling in HPLC, GC, and LC-MS analysis.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for tramadol.
• Process Chemistry R&D: Serves as a starting material or intermediate in route scouting and optimization for new chemical entities.
• Quality Control & Assurance: Essential for establishing identity, purity, and potency specifications in API manufacturing.
• Academic & Contract Research: Utilized in university and CRO settings for pharmacological and synthetic chemistry studies.

Basic Information

Product Name	n-Bis-Demethyl Tramadol
CAS No.	73806-40-3
Molecular Formula	C14H21NO2
Molecular Weight	235.33 g/mol
Synonyms	1-(3-Methoxyphenyl)-2-[(dimethylamino)methyl]cyclohexanol; O,O-Didesmethyltramadol; N,N-Bisdesmethyltramadol; Tramadol Impurity F; Tramadol Metabolite M5; U-26231A; 2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol
EINECS	Contact for details

Quality Control

Our n-Bis-Demethyl Tramadol is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical intermediates and reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%

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