Description

Ropinirole Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Ropinirole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ropinirole Impurity 5 in drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Ropinirole API and its formulations.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine impurity profiling in pharmaceutical manufacturing to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Ropinirole.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impurity's profile and behavior.

Basic Information

Product Name	Ropinirole Impurity 5
CAS No.	1800102-50-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one Impurity; Ropinirole Related Compound 5; Ropinirole EP Impurity E; Ropinirole USP Impurity; 2H-Indol-2-one, 1,3-dihydro-4-[2-(dipropylamino)ethyl]-, (Impurity of Ropinirole); SKF-101468 Impurity; ReQuip Impurity
EINECS	Contact for details

Quality Control

Every batch of Ropinirole Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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