Description

Safinamide Impurity 19 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 (API) 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.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Safinamide API.
• Method Development & Validation: Used in developing and validating chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing of Safinamide to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the formation pathway and properties of this specific impurity.

Basic Information

Product Name	Safinamide Impurity 19
CAS No.	1000370-25-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Safinamide Related Compound 19; Safinamide EP Impurity 19; Safinamide USP Impurity 19; (2S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide Impurity 19; Safinamide Process Impurity; Safinamide Degradant; Safinamide Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Safinamide Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and identity confirmation, is provided with each shipment.

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 handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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