Description

Tezacaftor is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the development of targeted therapies. This compound is critical for B2B buyers requiring reliable, consistent quality for advanced pharmaceutical manufacturing and research applications. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and chemical suppliers serving the life sciences sector for the production of combination treatments for cystic fibrosis.

Application

• Pharmaceutical API Synthesis: Key intermediate in the manufacture of Tezacaftor/Ivacaftor and Tezacaftor/Ivacaftor/Elexacaftor combination drugs.
• CFTR Modulator Research: Essential for preclinical and clinical research focused on cystic fibrosis transmembrane conductance regulator (CFTR) protein correction.
• Reference Standard: Serves as a high-purity analytical reference standard for quality control and regulatory testing.
• Process Development: Used in scaling up and optimizing synthetic routes for commercial-scale API production.
• Formulation Development: Employed in the development of final dosage forms, such as tablets, for combination therapies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for GMP production.

Basic Information

Product Name	Tezacaftor
CAS No.	1152311-62-0
Molecular Formula	C₂₆H₂₇F₃N₂O₆
Molecular Weight	520.50 g/mol
Synonyms	VX-661; N-(1,3-Dimethyl-2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-5-fluoro-1,3-dihydro-2-oxo-1-[[(2R)-2,2,2-trifluoro-1-[4-(2,2,2-trifluoroethoxy)phenyl]ethyl]carbamoyl]-1H-indole-3-carboxamide; 1H-Indole-3-carboxamide, N-(1,3-dihydro-1,3-dimethyl-2-oxo-2H-benzimidazol-5-yl)-5-fluoro-1,2-dihydro-2-oxo-1-[[(2R)-2,2,2-trifluoro-1-[4-(2,2,2-trifluoroethoxy)phenyl]ethyl]carbamoyl]-; Tezacaftor (VX-661); (R)-Tezacaftor
EINECS	Contact for details

Quality Control

Our Tezacaftor is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical use. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant ICH guidelines and can support development with specifications tailored to GMP standards for API manufacturing.

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 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 structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Meets 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.