Description

Safinamide is a highly selective and reversible monoamine oxidase B (MAO-B) inhibitor with sodium channel blocking activity. This compound is of significant commercial and therapeutic importance as the active pharmaceutical ingredient (API) in medications for the treatment of Parkinson's disease. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of advanced neurological therapies. Safinamide CAS NO 133866-14-5 represents a critical component in the synthesis of finished dosage forms, demanding the highest standards of purity and consistency.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key therapeutic agent in anti-Parkinson's drugs.
• Neurological Disorder Research: Used in preclinical and clinical research for studying MAO-B inhibition and its effects.
• Drug Formulation Development: Serves as a reference standard and raw material in the development of new tablet or capsule formulations.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, or NMR analysis.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale API production.
• Academic Research: Utilized in university and institutional research exploring novel applications for MAO inhibitors.

Basic Information

Product Name	Safinamide
CAS No.	133866-14-5
Molecular Formula	C17H19FN2O2
Molecular Weight	302.34 g/mol
Synonyms	FCE 26743; PNU-151774E; (S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]aminopropanamide; NW-1015; Xadago (Brand Name); Equfina (Brand Name); (2S)-2-[[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide; (S)-2-[[4-[(3-Fluorobenzyl)oxy]benzyl]amino]propanamide
EINECS	Contact for details

Quality Control

Our Safinamide is manufactured under strict quality management systems, ensuring it meets the stringent requirements for pharmaceutical intermediates and APIs. Quality is assured through comprehensive analytical testing, including HPLC for purity, chiral purity determination, and control of specified impurities. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with agreed specifications. We support compliance with major pharmacopeial standards (e.g., USP, EP) and ICH Q7 guidelines for active pharmaceutical ingredients.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Chiral Purity (Enantiomeric Excess)	≥99.0%
Related Substances (HPLC)	Total impurities ≤1.0%
Individual Unknown Impurity	≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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