Description

Rotigotine Sulfate Sodium is a high-purity pharmaceutical intermediate and active ingredient salt. This compound is critical for ensuring the stability and bioavailability of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of neurological therapeutics. Consistent quality and reliable supply are paramount for its intended applications.

Application

• Pharmaceutical Intermediate: Key synthetic precursor in the commercial production of the Rotigotine API.
• Neurological Drug Formulation: Used in the development and manufacturing of transdermal patches and other dosage forms for treating Parkinson's disease and Restless Legs Syndrome (RLS).
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Process Development & Scale-up: Employed in R&D for optimizing synthesis routes and scaling up production processes.
• Generic Drug Manufacturing: Essential for companies producing generic versions of rotigotine-based medications.
• Academic & Clinical Research: Used in preclinical and clinical studies to investigate the pharmacology and efficacy of rotigotine.

Basic Information

Product Name	Rotigotine Sulfate Sodium
CAS No.	131889-46-8
Molecular Formula	C19H25NO3S • Na • xH2O
Molecular Weight	Contact for details
Synonyms	(-)-5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthalenol sulfate sodium salt; (6S)-6-(Propyl(2-thiophen-2-ylethyl)amino)-5,6,7,8-tetrahydronaphthalen-1-ol sulfate sodium salt; SPM 962; Rotigotine sodium sulfate; Rotigotine sulphate sodium; Rotigotine Na salt
EINECS	Contact for details

Quality Control

Our Rotigotine Sulfate Sodium is manufactured under strict quality systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with your quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions 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% (on anhydrous basis)
Water Content (KF)	≤5.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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