Description

Siponimod is a potent and selective sphingosine-1-phosphate (S1P) receptor modulator. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of advanced therapeutics targeting specific immune-mediated pathways. It is primarily utilized by pharmaceutical companies and research institutions engaged in neurology and immunology. Siponimod CAS NO 916806-97-8 represents a key component in the production of innovative treatments.

Application

• Pharmaceutical API: Primary use as the active ingredient in the commercial manufacture of prescription medications.
• Multiple Sclerosis (MS) Treatment: Core component in formulations for secondary progressive multiple sclerosis (SPMS) therapy.
• Clinical Research: Serves as a reference standard and raw material for preclinical and clinical trial studies.
• Drug Development: Used in R&D for exploring new therapeutic applications of S1P receptor modulation.
• Formulation Development: Employed in the development of various dosage forms, including tablets.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for GMP production.

Basic Information

Product Name	Siponimod
CAS No.	916806-97-8
Molecular Formula	C29H35FN2O3
Molecular Weight	478.60 g/mol
Synonyms	BAF312; Mayzent; 1-{4-[(1E)-1-({[4-cyclohexyl-3-(trifluoromethyl)phenyl]amino}carbonyl)-2-cyclopropylethyl]-2-ethylbenzyl}azetidine-3-carboxylic acid; (E)-1-(4-(1-((4-cyclohexyl-3-(trifluoromethyl)phenyl)carbamoyl)-2-cyclopropylvinyl)-2-ethylbenzyl)azetidine-3-carboxylic acid; Siponimod free base
EINECS	Contact for details

Quality Control

Our Siponimod is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. Certificates of Analysis (COA) are provided with every shipment, detailing results from tests including HPLC assay, related substances, residual solvents, and heavy metals.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Loss on Drying	≤0.5%

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