Description

Safinamide Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Safinamide. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final drug product, which is used in the treatment of Parkinson's disease. It is an essential reference material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Safinamide Impurity 11 in Safinamide API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate control strategy.
• Process Chemistry & Optimization: Aids chemists in identifying the source of this impurity during API synthesis, enabling process refinement to minimize its formation.

Basic Information

Product Name	Safinamide Impurity 11
CAS No.	1843368-38-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Safinamide Related Compound 11; Safinamide EP Impurity 11; Safinamide USP Impurity 11; Safinamide Process Impurity 11; (2S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide Impurity 11; FCE 28073 Impurity 11; Xadago Impurity 11
EINECS	Contact for details

Quality Control

Our Safinamide Impurity 11 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.