Description

Ropinirole Hydrochloride CAS NO 91374-20-8 is a high-purity, non-ergoline dopamine agonist used as a critical active pharmaceutical ingredient (API). This compound is essential for the formulation of effective treatments for neurological disorders, primarily Parkinson's disease and Restless Legs Syndrome (RLS). It is a vital raw material for global pharmaceutical manufacturers engaged in the production of generic and branded medications, requiring stringent quality control and reliable supply chains.

Application

• Primary Pharmaceutical API: Manufacture of oral tablets for the treatment of Parkinson's disease.
• Neurological Disorder Treatment: Key ingredient in medications for managing moderate-to-severe Restless Legs Syndrome (RLS).
• Generic Drug Production: Sourcing for companies developing bioequivalent generic versions of ropinirole-based drugs.
• Clinical Research & Development: Used as a reference standard and raw material in preclinical and clinical studies for new neurological therapies.
• Pharmaceutical Intermediates: Serves as a crucial intermediate in complex synthetic routes for related dopaminergic agents.
• Regulatory Submissions: Supply of qualified material for Drug Master File (DMF) submissions and regulatory compliance dossiers (e.g., FDA, EMA).

Basic Information

Product Name	Ropinirole Hydrochloride
CAS No.	91374-20-8
Molecular Formula	C16H24N2O•HCl
Molecular Weight	296.84 g/mol
Synonyms	4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride; Ropinirole HCl; SKF-101468-A; Requip (brand name equivalent); Adartrel (brand name equivalent); Dopamine D2 Receptor Agonist; Non-ergot Dopamine Agonist
EINECS	Contact for details

Quality Control

Our Ropinirole Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmaceutical standards, typically conforming to USP/EP monograph requirements. We provide full traceability and Certificates of Analysis (COA) are available upon request, detailing purity, identity, and impurity profiles.

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.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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