Description

Fingolimod Impurity 13 is a specified impurity and reference standard used in the analytical profiling and quality control of Fingolimod hydrochloride, an active pharmaceutical ingredient. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of Fingolimod-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fingolimod API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure impurity levels are within ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support process optimization and impurity clearance studies.

Basic Information

Item	Detail
Product Name	Fingolimod Impurity 13
CAS No.	882691-14-7
Molecular Formula	C₁₉H₃₃NO₂
Molecular Weight	307.47 g/mol
Synonyms	2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; FTY720 Impurity 13; Fingolimod Related Compound 13; (2-Amino-2-{2-[4-(octyl)phenyl]ethyl}propane-1,3-diol); Gilenya Impurity 13; 2-Amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol; Fingolimod EP Impurity J
EINECS	Contact for details

Quality Control

Our Fingolimod Impurity 13 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS) to ensure identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

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) and must be kept in a dry environment. 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 (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.