Description

Safinamide Impurity 8 is a designated reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Safinamide, a medication used in the treatment of Parkinson's disease. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Safinamide API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to monitor impurity levels against established specifications.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of degradation products in Safinamide formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical properties of this specific impurity.

Basic Information

Product Name	Safinamide Impurity 8
CAS No.	690969-16-5
Molecular Formula	C17H19FN2O2
Molecular Weight	302.35 g/mol
Synonyms	(S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide; (S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide; Safinamide Related Compound; Safinamide Process Impurity; Safinamide Degradant; FCE 26743 Impurity; Xadago Impurity
EINECS	Contact for details

Quality Control

Every batch of Safinamide Impurity 8 is manufactured and controlled under a strict quality management system. The material is characterized and tested to meet high-purity standards suitable for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity (by HPLC), and specified impurities. Our quality protocols are designed to support compliance with ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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