Description

Safinamide is a highly selective and reversible monoamine oxidase B (MAO-B) inhibitor with potential sodium channel blocking activity. This compound is of significant commercial and research interest primarily for its application in the treatment of central nervous system disorders. It is a key active pharmaceutical ingredient (API) sought by pharmaceutical manufacturers, research institutions, and developers of neurological therapeutics. The material is supplied as a high-purity intermediate or finished API, meeting stringent quality standards for advanced pharmaceutical applications.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of prescription medications for Parkinson's disease, often in combination with levodopa.
• Neurological Research: Critical compound in preclinical and clinical research focused on MAO-B inhibition, neuroprotection, and motor function modulation.
• Drug Development: Serves as a reference standard and a building block in the development of new therapeutic agents targeting neurodegenerative conditions.
• Analytical Standard: Used in quality control laboratories as a high-purity reference material for HPLC, LC-MS, and other analytical method development and validation.
• Formulation Studies: Employed in the development of various dosage forms, including tablets and extended-release formulations, to optimize bioavailability and stability.

Basic Information

Product Name	Safinamide
CAS No.	133865-89-1
Molecular Formula	C17H19FN2O2
Molecular Weight	302.34 g/mol
Synonyms	(S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]aminopropanamide; FCE 26743; PNU-151774E; PNU-151774; EMD 1195686; Xadago (trade name); Safinamide Mesylate (salt form); (2S)-2-[[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide
EINECS	Contact for details

Quality Control

Our Safinamide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets the highest standards of identity, purity, and strength, typically conforming to pharmacopeial specifications (e.g., USP, EP). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting critical parameters including assay, related substances, residual solvents, and specific tests for identification. We are committed to supply chain transparency and regulatory compliance (e.g., cGMP, ICH Q7) for global pharmaceutical applications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Particle Size Distribution	Available upon request

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