Description

Fingolimod Impurity 8 is a specified impurity of the active pharmaceutical ingredient (API) Fingolimod HCl, a sphingosine 1-phosphate receptor modulator. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Fingolimod-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fingolimod HCl API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and accurately measure this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing to ensure Fingolimod drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Used to monitor the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Fingolimod Impurity 8
CAS No.	162358-96-5
Molecular Formula	C₁₉H₃₃NO₂
Molecular Weight	307.47 g/mol
Synonyms	(2S)-1-{2-[(1Z,3E)-4-[(2R)-2,3-Dihydroxypropyl]amino]-1,3-pentadien-1-yl}ethyl}cyclohexanol; (2S)-1-{(2E)-2-[(1Z,3E)-4-{[(2R)-2,3-Dihydroxypropyl]amino}-1,3-pentadien-1-yl]ethyl}cyclohexanol; FTY720 Impurity 8; Fingolimod Related Compound 8; Fingolimod EP Impurity G; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Impurity 8
EINECS	Contact for details

Quality Control

Our Fingolimod Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results for purity, related substances, and residual solvents. Our quality standards align with ICH guidelines to support your regulatory requirements.

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. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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