Description

Ropinirole Impurity C is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Ropinirole HCl. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Ropinirole API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, qualifying, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control and Release Testing: Essential for routine batch analysis in QC laboratories to ensure API and drug product purity meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies and Degradation Pathway Analysis: Employed to study the formation of this impurity under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize impurity formation.

Basic Information

Product Name	Ropinirole Impurity C
CAS No.	954117-24-9
Molecular Formula	C16H24N2O
Molecular Weight	260.38 g/mol
Synonyms	4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one; Ropinirole Related Compound C; Ropinirole EP Impurity C; Ropinirole USP Impurity C; Ropinirole Process Impurity; SKF-101468 Impurity; ADARTREL Impurity
EINECS	Contact for details

Quality Control

Every batch of Ropinirole Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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