Description

Tapentadol n-Oxide is a key pharmaceutical intermediate and reference standard of significant interest in research and development. This compound is primarily utilized in the synthesis and analytical characterization of the centrally-acting analgesic Tapentadol, ensuring product quality and process understanding. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on pain management therapeutics. The compound's defined structure makes it a critical tool for method development, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the active pharmaceutical ingredient (API) Tapentadol.
• Reference Standard: Used for the identification, assay, and impurity quantification of Tapentadol in drug substances and finished products via analytical techniques like HPLC and LC-MS.
• Impurity Profiling: Serves as a certified reference material to monitor and control process-related impurities during Tapentadol API manufacturing.
• Metabolite Studies: Employed in pharmacological and toxicological research to study the metabolism and degradation pathways of Tapentadol.
• Method Development & Validation: Essential for developing and validating robust analytical methods in quality control (QC) laboratories.
• Regulatory Submissions: Provides necessary data and materials for regulatory filings (e.g., with FDA, EMA) to demonstrate understanding and control of the drug substance.

Basic Information

Item	Detail
Product Name	Tapentadol n-Oxide
CAS No.	1346601-17-9
Molecular Formula	C14H23NO3
Molecular Weight	253.34 g/mol
Synonyms	Tapentadol N-Oxide; 3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol 1-Oxide; Tapentadol Impurity; Tapentadol Related Compound; Nucynta Impurity; (1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol N-Oxide; Tapentadol Metabolite; GRT-6005 N-Oxide
EINECS	Contact for details

Quality Control

Our Tapentadol n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical reference standards and intermediates. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (typically ≥95% by HPLC), and impurity profile. We support compliance with cGMP, ICH Q7, and relevant pharmacopeial guidelines.

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 prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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