Description

Safinamide Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Safinamide, a medication used in the treatment of Parkinson's disease. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Safinamide API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity profiles and establishing specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation and understand the degradation pathways of Safinamide.
• Process Chemistry Research: Used in research and development to optimize synthesis routes, minimize impurity formation, and ensure process robustness.
• Pharmacopoeial Testing: Applied in testing to meet the requirements of various pharmacopoeias (e.g., USP, EP, JP) for related substance analysis.

Basic Information

Product Name	Safinamide Impurity 5
CAS No.	1160513-60-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Safinamide Related Compound 5; (2E)-3-(3,4-Difluorophenyl)-2-propenamide; (E)-3-(3,4-Difluorophenyl)acrylamide; Safinamide Impurity E; (E)-3-(3,4-Difluorophenyl)prop-2-enamide; UNII-6W3V8YV8QN; 2-Propenamide, 3-(3,4-difluorophenyl)-, (2E)-; A potential degradation product or process-related impurity of Safinamide.
EINECS	Contact for details

Quality Control

Every batch of Safinamide Impurity 5 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and impurity profiles. Our quality standards are designed to support compliance with cGMP, ICH Q3A/B guidelines, and other relevant regulatory frameworks for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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