Description

Rotigotine Hydrochloride is a high-purity, non-ergoline dopamine agonist used as a critical active pharmaceutical ingredient (API). It is essential for the formulation of advanced transdermal therapies, primarily for the treatment of Parkinson's disease and Restless Legs Syndrome (RLS). This compound is supplied to pharmaceutical manufacturers and research institutions globally, requiring stringent quality control for drug development and production.

Application

• Pharmaceutical API: Primary active ingredient in transdermal patch formulations for neurological disorders.
• Parkinson's Disease Treatment: Used in continuous dopaminergic stimulation therapies to manage motor symptoms.
• Restless Legs Syndrome (RLS) Therapy: Key component in patches designed for long-term symptom control.
• Neurological Research: Reference standard and investigational material for studying dopamine receptor activity.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent transdermal generic medications.
• Drug Delivery System Development: Used in R&D for novel transdermal and sustained-release delivery platforms.

Basic Information

Product Name	Rotigotine Hydrochloride
CAS No.	125572-92-1
Molecular Formula	C19H26ClNO2S
Molecular Weight	367.93 g/mol
Synonyms	(-)-5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthalenol Hydrochloride; N-0923 Hydrochloride; Rotigotine HCl; (6S)-6-[Propyl(2-thiophen-2-ylethyl)amino]-5,6,7,8-tetrahydronaphthalen-1-ol Hydrochloride; SPM 962 Hydrochloride; Dopamine D2 Receptor Agonist Rotigotine Hydrochloride
EINECS	Contact for details

Quality Control

Our Rotigotine Hydrochloride is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing, including chiral purity verification and impurity profiling. A Certificate of Analysis (COA) detailing identity, assay, related substances, residual solvents, and microbiological data is provided with every shipment to ensure traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (HPLC)	≥ 99.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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