Description

Fingolimod n-Methyl Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fingolimod. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Fingolimod API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure Fingolimod batches meet pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Process Chemistry Research: Used to study the formation and fate of this specific impurity during the synthesis, purification, and scale-up of Fingolimod.
• Stability Studies: Employed to track the potential formation or increase of this impurity in drug substances and products under various storage conditions over time.

Basic Information

Product Name	Fingolimod n-Methyl Impurity
CAS No.	1404233-80-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fingolimod N-Methylated Impurity; Fingolimod Related Compound n-Methyl; 2-Amino-2-[2-(4-octylphenyl)ethyl]propan-1-ol, N-methyl derivative; FTY720 n-Methyl Impurity; Gilenya Impurity (n-Methyl); Sphingosine 1-Phosphate Receptor Modulator Impurity; (2R)-2-[[(1E,3R)-3-Hydroxy-5-phenyl-1-penten-1-yl]amino]propan-1-ol, N-methyl variant (proposed); Fingolimod EP Impurity G (if applicable)
EINECS	Contact for details

Quality Control

Our Fingolimod n-Methyl Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and confirmed using advanced techniques such as HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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