Description

Rac-Rotigotine Hydrochloride is a non-selective dopamine receptor agonist used as a key intermediate and reference standard in pharmaceutical research and development. Its significance lies in its role in the synthesis and analytical characterization of the active pharmaceutical ingredient Rotigotine, a medication used to treat Parkinson's disease and Restless Legs Syndrome. This high-purity chemical is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in process development, quality control, and clinical studies.

Application

• Pharmaceutical Intermediate: Critical raw material in the synthesis of the active pharmaceutical ingredient (API) Rotigotine.
• Analytical Reference Standard: Used for method development, validation, and quality control (QC) testing in HPLC, GC, and other chromatographic systems.
• Pharmacological Research: Serves as a tool compound for studying dopamine receptor activity, pharmacokinetics, and metabolic pathways.
• Impurity Profiling: Employed to identify and quantify related substances and degradation products in API and finished drug product batches.
• Process Chemistry: Used in scale-up studies and optimization of synthetic routes for Rotigotine production.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Rac-Rotigotine Hydrochloride
CAS No.	102120-99-0
Molecular Formula	C19H26ClNOS
Molecular Weight	351.93 g/mol
Synonyms	(±)-Rotigotine Hydrochloride; (RS)-Rotigotine HCl; 6-[Propyl[2-(2-thienyl)ethyl]amino]-5,6,7,8-tetrahydro-1-naphthalenol Hydrochloride; SPM 962 Hydrochloride (racemic); N-0923 Hydrochloride (racemic); 5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthol Hydrochloride
EINECS	Contact for details

Quality Control

Our Rac-Rotigotine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical intermediates and reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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