Description

Fingolimod Impurity A Hydrochloride is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of process-related impurities in the synthesis of Fingolimod hydrochloride, an active pharmaceutical ingredient (API). It is primarily used by analytical chemists and quality control professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the accurate identification and quantification of Fingolimod Impurity A in drug substances and products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker to track impurity formation during forced degradation and long-term stability studies of Fingolimod API and formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the manufacturing process.
• Process Chemistry Research: Aids chemists in understanding synthetic pathways and optimizing reaction conditions to minimize the formation of this specific impurity.

Basic Information

Product Name	Fingolimod Impurity A Hydrochloride
CAS No.	1343408-33-2
Molecular Formula	C19H34ClNO2
Molecular Weight	343.93 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Hydrochloride; FTY720 Impurity A HCl; (R)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Hydrochloride; Fingolimod EP Impurity A HCl; Fingolimod Related Compound A Hydrochloride; S1P Receptor Modulator Impurity A HCl; Gilenya Impurity A Hydrochloride
EINECS	Contact for details

Quality Control

Our Fingolimod Impurity A Hydrochloride is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, MS, and other relevant tests. We adhere to high standards suitable for pharmaceutical reference material applications, supporting compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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%
Residue on Ignition	≤ 0.1%

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