Description

Tapentadol-D5 n-Oxide is a deuterated analog of the Tapentadol metabolite, specifically designed for use as an analytical reference standard. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analysis in complex matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities for method development, validation, and quality control of pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of Tapentadol and its metabolites in biological samples (e.g., plasma, urine) using LC-MS/MS and GC-MS.
• Metabolite Studies: Critical for pharmacokinetic (PK) and pharmacodynamic (PD) research, enabling the tracking and measurement of the n-Oxide metabolite pathway in drug metabolism studies.
• Bioanalytical Method Development: Used to develop, optimize, and validate highly sensitive and specific analytical methods, improving accuracy and reducing matrix effects.
• Forensic and Clinical Toxicology: Supports accurate identification and quantification in forensic analysis and therapeutic drug monitoring (TDM) programs.
• Impurity Profiling: Acts as a marker for stability testing and impurity characterization in active pharmaceutical ingredient (API) and finished drug product analysis.
• Regulatory Compliance and Submission: Provides essential data to meet stringent regulatory requirements (e.g., FDA, EMA) for drug approval and post-market surveillance.

Basic Information

Product Name	Tapentadol-D5 n-Oxide
CAS No.	1346603-32-4
Molecular Formula	C14H18D5NO2
Molecular Weight	236.35 g/mol
Synonyms	3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]-D5-phenol N-Oxide; (1R,2R)-3-(Dimethyl-D6-amino)-1-ethyl-2-methylpropyl-D5 phenol N-Oxide; Deuterated Tapentadol N-Oxide; Tapentadol-D5 N-Oxide-d6; Tapentadol metabolite D5 N-Oxide; Deuterium Labeled Tapentadol N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Tapentadol-D5 n-Oxide is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail purity, isotopic enrichment, and impurity profiles, ensuring traceability and compliance with relevant pharmacopeial guidelines for reference standards. Our products undergo rigorous quality testing to ensure compliance with industry standards.

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. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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