Description

10β-Hydroxyl Dextrorphan 3-o-β-D-Glucuronide is a high-purity reference standard and key metabolite of dextrorphan, the primary active metabolite of the antitussive agent dextromethorphan. This compound is of critical importance for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK) studies. It serves as an essential analytical standard for laboratories conducting bioanalytical method development, clinical toxicology, and forensic analysis to accurately quantify and understand the metabolic pathways of dextromethorphan.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of bioanalytical methods.
• Drug Metabolism & Pharmacokinetics (DMPK): Critical for in vitro and in vivo studies to identify and quantify major metabolic pathways of dextromethorphan.
• Clinical Toxicology & Forensic Analysis: Used as a definitive standard in assays to detect and confirm the presence of dextromethorphan metabolites in biological samples (e.g., blood, urine).
• Biomedical Research: Employed in neuroscience and pharmacology research to study the effects and clearance of dextrorphan-related compounds.
• Quality Control in Pharma Manufacturing: Ensures the accuracy and reliability of impurity profiling and stability testing for dextromethorphan-based pharmaceutical products.
• Regulatory Submissions: Provides essential 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	10β-Hydroxyl Dextrorphan 3-o-β-D-Glucuronide
CAS No.	1399983-86-8
Molecular Formula	C23H31NO9
Molecular Weight	465.50 g/mol
Synonyms	10β-Hydroxydextrorphan 3-O-β-D-glucuronide; Dextrorphan-3-O-β-D-glucuronide, 10β-hydroxy-; 10β-Hydroxydextrorphan glucuronide; 10β-OH-Dextrorphan glucuronide; Dextrorphan metabolite M2; (9α,13α,14α)-3-(β-D-Glucopyranuronosyloxy)-17-methylmorphinan-10β,17-diol; 17-Methylmorphinan-10β,17-diol 3-(β-D-glucopyranosiduronic acid)
EINECS	Contact for details

Quality Control

Our 10β-Hydroxyl Dextrorphan 3-o-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to guarantee traceability, identity, and purity for your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. For long-term storage, the product should be kept under an inert atmosphere. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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