Description

Tapentadol o-β-D-Glucuronide is a major, pharmacologically inactive metabolite of the centrally-acting analgesic tapentadol, formed via glucuronidation. This reference standard is critical for analytical and bioanalytical research, enabling precise quantification and metabolic profiling in biological matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology units for method development, validation, and quality control in drug metabolism and pharmacokinetics (DMPK) studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the calibration of analytical instruments and the validation of bioanalytical methods.
• Metabolite Identification & Quantification: Essential for in vitro and in vivo DMPK studies to identify, characterize, and quantify tapentadol metabolites.
• Clinical Trial Support: Used in the bioanalysis of clinical samples to monitor tapentadol and its metabolite levels for pharmacokinetic and safety assessments.
• Forensic and Toxicology Analysis: A key component in assays for detecting and confirming tapentadol use in forensic investigations and workplace drug testing.
• Impurity Profiling: Employed as a known impurity or degradation product standard in the stability testing and quality control of tapentadol active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Provides critical data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Tapentadol o-β-D-Glucuronide
CAS No.	1300037-86-8
Molecular Formula	C23H33NO9
Molecular Weight	467.51 g/mol
Synonyms	Tapentadol O-Glucuronide; Tapentadol Glucuronide; (1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol O-β-D-Glucuronide; Tapentadol Metabolite; Tapentadol D6 Glucuronide (isotopic analog); NU-3 Glucuronide; CG5503 O-Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Tapentadol o-β-D-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and stability testing to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), identity confirmation (by NMR and MS), and impurity profile is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This compound is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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