Description

Tezacaftor is a high-purity, small-molecule pharmaceutical intermediate and active ingredient. It is a critical component in the development and manufacture of targeted therapies for cystic fibrosis, functioning as a CFTR corrector. This compound is essential for pharmaceutical manufacturers, research institutions, and CDMOs engaged in the production of innovative respiratory and genetic disorder treatments. Our supply of Tezacaftor CAS NO 381212-03-9 is characterized by stringent quality control and reliable scalability.

Application

• Pharmaceutical Active Ingredient (API): Primary use as a key component in combination therapies for cystic fibrosis (CF).
• Research & Development: Utilized in preclinical and clinical studies for investigating CFTR modulator mechanisms and efficacy.
• Drug Formulation: Incorporated into final dosage forms such as tablets or granules in combination with other CFTR modulators like ivacaftor and elexacaftor.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical labs.
• Process Chemistry: Used as a critical intermediate in the synthetic pathways for advanced pharmaceutical manufacturing.

Basic Information

Product Name	Tezacaftor
CAS No.	381212-03-9
Molecular Formula	C26H27F3N2O5
Molecular Weight	504.50 g/mol
Synonyms	VX-661; N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide; 1-(2,2-Difluoro-1,3-benzodioxol-5-yl)-N-[1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl]cyclopropanecarboxamide; Tezacaftor (VX-661); VX 661; VX661
EINECS	Contact for details

Quality Control

Our Tezacaftor is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure compliance with ICH guidelines and customer-specific requirements. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting purity, impurities, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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