Description

n-Desmethyl-cis-Tramadol Hcl is a key pharmaceutical intermediate and reference standard, specifically the cis-isomer of the desmethyl metabolite of tramadol. This compound is of significant importance for analytical research, method development, and quality control in the pharmaceutical industry. It is primarily needed by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in the development, testing, and regulatory compliance of tramadol-based medications and their metabolic pathways.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified standard for the quantitative and qualitative analysis of tramadol and its metabolites in drug substances and finished products.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the pharmacokinetics, pharmacodynamics, and metabolic profile of tramadol.
• Analytical Method Development: Serves as a critical component in developing and validating chromatographic methods (HPLC, LC-MS) for impurity profiling and assay determination.
• Quality Control & Assurance: Employed in internal QC laboratories to ensure the identity, purity, and consistency of active pharmaceutical ingredients (APIs) and to monitor for specific related substances.
• Forensic and Clinical Toxicology: Used as a calibrant or control in assays designed to detect and quantify tramadol metabolites in biological matrices for forensic or diagnostic purposes.
• Regulatory Compliance & Documentation: Supports regulatory filings by providing definitive characterization data for impurities or degradation products as required by ICH guidelines.

Basic Information

Product Name	n-Desmethyl-cis-Tramadol Hcl
CAS No.	1018989-94-0
Molecular Formula	C15H23NO2•HCl
Molecular Weight	285.81 g/mol (as free base: 249.35 g/mol)
Synonyms	(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride; O-Desmethyl-cis-Tramadol Hydrochloride; cis-O-Desmethyltramadol HCl; (1R,2R)-Tramadol Metabolite M1 Hydrochloride; (+)-cis-O-Desmethyltramadol Hydrochloride; PC-409 Hcl; CRM-10905
EINECS	Contact for details

Quality Control

Our n-Desmethyl-cis-Tramadol Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, HPLC), assay (HPLC), and detailed impurity profiling to ensure it meets the high-purity standards required for reference materials and pharmaceutical intermediates. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤0.5% Total impurities: ≤2.0%
Specific Rotation	Contact for details

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