Description

Voclosporin is a novel, potent calcineurin inhibitor specifically developed for the treatment of autoimmune diseases. This small molecule drug substance represents a significant advancement in targeted immunosuppressive therapy, offering a refined mechanism of action. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of advanced therapeutics for conditions such as lupus nephritis.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key therapeutic component in formulated drug products.
• Lupus Nephritis Treatment: Clinical development and commercial manufacturing of medications for this serious kidney complication of systemic lupus erythematosus (SLE).
• Immunology Research: A critical tool for in-vitro and in-vivo studies exploring T-cell activation and calcineurin pathway inhibition.
• Drug Formulation Development: Used in R&D for creating various dosage forms, including oral capsules and tablets.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in laboratories.
• Process Chemistry & Scale-Up: Employed in the optimization and validation of synthetic routes for commercial-scale API production.

Basic Information

Product Name	Voclosporin
CAS No.	515814-01-4
Molecular Formula	C63H113N11O12
Molecular Weight	1216.64 g/mol
Synonyms	VOCLOSPORIN; ISA247; LX211; (1S,2R,3R,4S)-4-[(2E)-2-[(1R,3S,5S)-5-[(1S)-2-[(2S,4R,5S)-5-Ethyl-5-[(1R,2R,5S,6S)-5-hydroxy-2-methyl-6-(prop-1-en-2-yl)cyclohexyl]-4-methoxy-2-methyltetrahydro-2H-pyran-4-yl]-1-hydroxyethyl]-3-methyl-6-oxabicyclo[3.2.1]octan-8-ylidene]ethyl]-2-methylcyclohexane-1,2,3,4-tetrol; Modified Cyclosporine A analog
EINECS	Contact for details

Quality Control

Our Voclosporin is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical development and production. Each batch is subjected to comprehensive analytical testing, including identity, purity, and impurity profile verification via advanced techniques like HPLC and mass spectrometry. A Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified on the label. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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