Description

Fingolimod Methyl Impurity is a designated chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fingolimod. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for identifying and quantifying a specific process-related impurity. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Fingolimod-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development & Validation: Critical for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to separate and quantify impurities.
• Quality Control (QC) Testing: Used in routine batch release testing of Fingolimod API to monitor and control impurity levels, ensuring compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development: Facilitates process chemistry research aimed at minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Fingolimod Methyl Impurity
CAS No.	162361-47-9
Molecular Formula	C20H33NO2
Molecular Weight	319.48 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol methyl derivative; FTY720 Methyl Impurity; Fingolimod EP Impurity G; Fingolimod Related Compound G; (2R)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol methyl ester; 162361-47-9; Gilenya Impurity
EINECS	Contact for details

Quality Control

Our Fingolimod Methyl Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support GMP-grade requirements for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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