Description

o-Demethyl-n-Demethyl Tramadol is a key pharmaceutical intermediate and reference standard of significant analytical importance. This compound is primarily utilized in research and development for the synthesis and quality control of related active pharmaceutical ingredients (APIs). It serves as a critical tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: Used in the research and synthesis of tramadol analogs and related opioid analgesics.
• Analytical Reference Standard: Serves as a certified standard for the identification and quantification of impurities and metabolites in pharmaceutical products.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for tramadol and its derivatives.
• Quality Control (QC) Testing: Essential for HPLC, GC, and LC-MS method development and validation in pharmaceutical QC laboratories.
• Regulatory Compliance: Used to support regulatory filings (e.g., with FDA, EMA) by providing impurity characterization data.
• Forensic Analysis: Applied as a reference material in forensic toxicology for the detection and confirmation of substances.

Basic Information

Product Name	o-Demethyl-n-Demethyl Tramadol
CAS No.	189893-11-6
Molecular Formula	C15H23NO2
Molecular Weight	249.35 g/mol
Synonyms	N,O-Didesmethyltramadol; 2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol; O-Desmethyl-N-desmethyltramadol; Tramadol Impurity G; Tramadol Metabolite M4; U-09307; 1-(3-Methoxyphenyl)-2-[(dimethylamino)methyl]cyclohexan-1-ol
EINECS	Contact for details

Quality Control

Our o-Demethyl-n-Demethyl Tramadol is produced under strict quality management systems to ensure high purity and batch-to-batch consistency, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as determined by advanced chromatographic techniques. We support compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.