Description

Rotigotine Impurity 19 (Rotigotine Ep Impurity F) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the active pharmaceutical ingredient (API) Rotigotine. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require precise impurity profiling and method validation to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Rotigotine API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions during drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Research & Development: Used in synthetic chemistry R&D to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Rotigotine Impurity 19 (Rotigotine Ep Impurity F)
CAS No.	835654-68-7
Molecular Formula	C19H25NOS
Molecular Weight	315.48 g/mol
Synonyms	Rotigotine EP Impurity F; Rotigotine Related Compound F; (6S)-6-[Propyl(2-thiophen-2-ylethyl)amino]-5,6,7,8-tetrahydronaphthalen-1-ol; Rotigotine Impurity F; Rotigotine Process Impurity; Neupro Impurity F; S(-)-5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthalenol; Rotigotine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Rotigotine Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity, chromatographic data, and structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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