Description

Safinamide Impurity 9 is a high-purity 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 research institutions for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the analytical profiling of Safinamide API.
• Critical component in HPLC and LC-MS method development and validation for impurity detection.
• Used in stability studies and forced degradation studies to monitor impurity formation.
• Essential for quality control (QC) and quality assurance (QA) laboratories in pharmaceutical manufacturing.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing impurity identity and purity data.
• Valuable for academic and clinical research investigating the metabolism and degradation pathways of Safinamide.

Basic Information

Product Name	Safinamide Impurity 9
CAS No.	1000370-28-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Safinamide Related Compound 9; Safinamide Impurity; (S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide Impurity; 1000370-28-4; UNII-Contact for details; Safinamide Process Impurity; Safinamide Degradant
EINECS	Contact for details

Quality Control

Our Safinamide Impurity 9 is manufactured under controlled conditions to ensure the highest standards of purity and consistency. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications. We support our clients in meeting the stringent requirements of GMP, ICH Q3A/B guidelines, and global regulatory standards.

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) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for prolonged operations.

Specification

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

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