Description

Rac Rotigotine-D3 Hydrochloride Salt is a deuterated isotopologue of the non-ergoline dopamine agonist Rotigotine, specifically designed for use as a high-purity internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic stability studies. It is an essential material for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments requiring precise deuterium-labeled reference standards.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry for bioanalytical method development and validation.
• Pharmacokinetic Studies: Enables accurate measurement of Rotigotine concentration in biological matrices (plasma, serum, tissue) during ADME (Absorption, Distribution, Metabolism, Excretion) studies.
• Metabolite Identification: Aids in the detection and structural elucidation of Rotigotine metabolites using mass spectrometry due to its predictable mass shift.
• Pharmaceutical Quality Control: Used in impurity profiling and assay development for Rotigotine-based drug products and active pharmaceutical ingredients (APIs).
• Stability-Indicating Methods: Supports the development of analytical methods to monitor the stability of Rotigotine under various stress conditions.
• Clinical Research: Facilitates reliable data generation in clinical trials for Parkinson's disease and Restless Legs Syndrome (RLS) treatments.

Basic Information

Product Name	Rac Rotigotine-D3 Hydrochloride Salt
CAS No.	1215846-20-0
Molecular Formula	C19H22D3NO2S • HCl
Molecular Weight	369.96 g/mol (for monoisotopic mass)
Synonyms	Rotigotine-d3 HCl; (6S)-6-[Propyl(2-thiophen-2-ylethyl)amino]-5,6,7,8-tetrahydro-1-naphthalenol-d3 Hydrochloride; (S)-(-)-N-0434-d3 Hydrochloride; N-0923-d3 Hydrochloride; Deuterated Rotigotine Hydrochloride; Rac Rotigotine (propyl-d3) Hydrochloride; 2-(N-Propyl-d3-N-2-thienylethylamino)-5-hydroxytetralin Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Rac Rotigotine-D3 Hydrochloride Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment. Our quality commitment aligns with standards expected for high-value reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, isotopic purity, and related substances by HPLC. We support compliance needs for research under GLP (Good Laboratory Practice) and cGMP (current Good Manufacturing Practice) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). Due to its hygroscopic nature, the product should be stored in a dry environment. For long-term storage, consider desiccants. Keep the container sealed under an inert atmosphere (e.g., nitrogen or argon) after opening to minimize moisture uptake and ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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