Description

Safinamide Mesylate CAS NO 202825-46-5 is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is a selective and reversible monoamine oxidase B (MAO-B) inhibitor, making it a critical component in the development of advanced neurological therapeutics. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the synthesis of innovative treatments for Parkinson's disease and related central nervous system disorders.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the commercial production of anti-Parkinson's drugs.
• Neurological Research: A key compound in preclinical and clinical research for studying MAO-B inhibition and its effects on neurodegenerative pathways.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Process Development: Used in the development and optimization of scalable synthetic routes for new chemical entities (NCEs) in CNS drug discovery.
• Formulation Studies: Employed in the development of various dosage forms, including tablets and capsules, to assess stability and bioavailability.

Basic Information

Product Name	Safinamide Mesylate
CAS No.	202825-46-5
Molecular Formula	C17H19FN2O2 • CH4O3S
Molecular Weight	398.45 g/mol
Synonyms	Safinamide methanesulfonate; (S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]aminopropanamide methanesulfonate; FCE 26743; PNU-151774E; Xadago (brand name salt form); NW-1015; EMD 1195686
EINECS	Contact for details

Quality Control

Our Safinamide Mesylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC assay, chiral purity, residual solvents, and heavy metals, in compliance with ICH guidelines.

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 under dry, inert conditions 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 matches reference standard
Assay (HPLC)	≥ 98.5%
Chiral Purity (Enantiomeric Excess)	≥ 99.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
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.