Description

Tapentadol-D5 Hydrochloride is a deuterated isotopologue of the centrally-acting analgesic Tapentadol, specifically labeled with five deuterium atoms. This compound serves as a critical internal standard in quantitative bioanalytical methods, ensuring high accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities involved in the development and quality control of analgesic medications.

Application

• Primary use as a stable isotope-labeled internal standard for the precise quantification of Tapentadol in biological matrices (e.g., plasma, serum, urine) via LC-MS/MS and GC-MS.
• Essential for conducting pharmacokinetic (PK) and bioequivalence studies for generic and novel Tapentadol formulations.
• Facilitates metabolite identification and profiling research to understand drug metabolism pathways.
• Supports forensic and clinical toxicology analyses for accurate drug level monitoring.
• Used in method development and validation in accordance with FDA, EMA, and ICH guidelines.
• Critical for quality control and assurance in pharmaceutical manufacturing where trace analysis is required.

Basic Information

Product Name	Tapentadol-D5 Hydrochloride
CAS No.	1217724-63-4
Molecular Formula	C14H18D5NO•HCl
Molecular Weight	266.85 g/mol (approx.)
Synonyms	3-[(1R,2R)-3-(Dimethylamino-d6)-1-ethyl-2-methylpropyl]phenol Hydrochloride; (1R,2R)-3-(Dimethyl-d6-amino)-1-ethyl-2-methylpropylphenol Hydrochloride; Tapentadol-d5 HCl; Tapentadol (phenyl-D5) Hydrochloride; Nucynta-D5 Hydrochloride; Palexia-D5 Hydrochloride; CG5503-D5 Hydrochloride
EINECS	Contact for details

Quality Control

Our Tapentadol-D5 Hydrochloride is manufactured under controlled conditions to ensure exceptional isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing isotopic enrichment (typically ≥98% D), chemical purity (by HPLC), and confirming identity via spectroscopic methods. We adhere to stringent quality management systems to guarantee batch-to-batch consistency and reliability for your critical research and development needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider desiccated environments.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (Mass Spectrometry)	Conforms to structure
Isotopic Purity (Deuterium Enrichment)	≥98 atom % D
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Specific Optical Rotation	Contact for details

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