Description

Fingolimod Impurity 2 is a specified impurity of the active pharmaceutical ingredient Fingolimod HCl, used in the treatment of multiple sclerosis. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Fingolimod-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fingolimod HCl drug substance and finished products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical QC labs to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand impurity formation pathways and develop purification processes.

Basic Information

Product Name	Fingolimod Impurity 2
CAS No.	860629-08-9
Molecular Formula	C₁₉H₃₃NO₂
Molecular Weight	307.47 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; FTY720 Impurity 2; (R)-2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Gilenya Impurity 2; Fingolimod Related Compound B; Fingolimod EP Impurity B; Sphingosine 1-Phosphate Receptor Modulator Impurity
EINECS	Contact for details

Quality Control

Every batch of Fingolimod Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR 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.

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 should 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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