Description

Ropinirole Ep Impurity C Hcl CAS NO 784110-47-0 is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Ropinirole. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard for the identification and quantification of Ropinirole-related impurities.
• Analytical Method Development and Validation in HPLC, UPLC, and LC-MS systems.
• Quality Control and Assurance (QC/QA) testing of Ropinirole Hydrochloride API and finished dosage forms.
• Stability Studies to monitor impurity profiles under various stress conditions.
• Regulatory Compliance and Documentation for submissions to agencies like the US FDA and EMA.
• Research and Development of synthetic pathways and purification processes for Ropinirole.

Basic Information

Product Name	Ropinirole Ep Impurity C Hcl
CAS No.	784110-47-0
Molecular Formula	C16H24N2O.HCl
Molecular Weight	296.84 g/mol
Synonyms	4-[2-(Dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride; Ropinirole Related Compound C; Ropinirole Impurity C HCl; Ropinirole EP Impurity C; SKF-101468 Impurity C; ADARTREL Impurity C; REQUIP Impurity C; 2H-Indol-2-one, 1,3-dihydro-4-[2-(dipropylamino)ethyl]-, hydrochloride (1:1)
EINECS	Contact for details

Quality Control

Our Ropinirole Ep Impurity C Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and research needs.

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 material 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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