Description

Ivacaftor is a highly potent and selective CFTR potentiator, a small-molecule pharmaceutical active ingredient. It is a cornerstone therapeutic agent for treating cystic fibrosis in patients with specific gating mutations in the CFTR gene. This compound is essential for pharmaceutical manufacturers and research institutions developing targeted therapies for respiratory diseases. Its precise mechanism of action makes it a critical component in advanced drug formulations.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key therapeutic component in finished drug products for the treatment of cystic fibrosis (CF).
• Combination Therapies: Used in fixed-dose combination products, such as with lumacaftor or tezacaftor, for enhanced efficacy in CF treatment.
• Clinical Research: Serves as a reference standard and investigational material in preclinical and clinical studies for CF and related channelopathies.
• Drug Development: Utilized in formulation development, stability testing, and bioavailability studies for new CF therapeutics.
• Analytical Standard: Employed as a high-purity standard for quality control (QC) and analytical method development (e.g., HPLC, LC-MS) in pharmaceutical labs.

Basic Information

Product Name	Ivacaftor
CAS No.	873054-44-5
Molecular Formula	C₂₄H₂₈N₂O₃
Molecular Weight	392.49 g/mol
Synonyms	VX-770; N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide; Kalydeco (Brand Name); Ivacaftorum; 3-Quinolinecarboxamide, N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-
EINECS	Contact for details

Quality Control

Our Ivacaftor is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) documenting identity, purity, and impurity profiles are available for every batch. Our quality commitment aligns with cGMP principles to support our clients' regulatory submissions and production needs.

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. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
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.