Description

Fingolimod Deshydroxymethyl Impurity is a key process-related impurity and degradation product associated with the active pharmaceutical ingredient Fingolimod HCl. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for method validation and quality control. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require high-purity materials to ensure the safety, efficacy, and regulatory compliance of drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of deshydroxymethyl Fingolimod in Fingolimod HCl drug substance and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release Testing: Employed in routine QC labs to ensure drug substance and product batches meet stringent ICH Q3A/B impurity thresholds.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Fingolimod Deshydroxymethyl Impurity
CAS No.	168560-42-7
Molecular Formula	C₁₉H₃₃NO₂
Molecular Weight	307.47 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Deshydroxymethyl Fingolimod; Fingolimod Impurity D; Fingolimod EP Impurity D; Fingolimod Related Compound D; FTY720 Deshydroxymethyl Impurity; FTY720 Impurity D; (R)-2-Amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol
EINECS	Contact for details

Quality Control

Our Fingolimod Deshydroxymethyl Impurity is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical testing, including HPLC purity determination, residual solvent analysis, and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

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 COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 2.0%
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.