Description

3-Oxo Ropinirole (Ropinirole Impurity C) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of Ropinirole hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a marker for specific synthetic pathways and degradation products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Ropinirole Impurity C in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurities during API synthesis.
• Stability and Forced Degradation Studies: Employed to understand the degradation profile of Ropinirole and establish appropriate shelf-life and storage conditions.
• Quality Control & Batch Release Testing: A critical component in the QC testing suite to ensure API batches meet ICH, USP, or EP impurity limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used by R&D scientists to study and optimize the synthesis of Ropinirole, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	3-Oxo Ropinirole (Ropinirole Impurity C)
CAS No.	102842-51-3
Molecular Formula	C16H24N2O2
Molecular Weight	276.38 g/mol
Synonyms	4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one; Ropinirole Impurity C; Ropinirole Related Compound C; SKF-101468 Impurity; 2H-Indol-2-one, 1,3-dihydro-4-[2-(dipropylamino)ethyl]-; 4-[2-(Dipropylamino)ethyl]indolin-2-one
EINECS	Contact for details

Quality Control

Our 3-Oxo Ropinirole is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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