Description

Kalydeco Hydrate is the hydrated form of Ivacaftor, a highly specific and potent CFTR potentiator used to treat cystic fibrosis in patients with specific gating mutations. This active pharmaceutical ingredient (API) is critical for formulating life-changing therapies that address the underlying cause of the disease rather than just its symptoms. It is essential for global pharmaceutical manufacturers engaged in the development and production of targeted cystic fibrosis treatments, requiring the highest standards of purity, consistency, and regulatory compliance.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of Kalydeco® (ivacaftor) tablets for the treatment of cystic fibrosis.
• Precision Medicine: Formulation of therapies targeting patients with the G551D mutation and other gating mutations in the CFTR gene.
• Combination Therapies: Used in fixed-dose combination products, such as with lumacaftor (Orkambi®) or tezacaftor (Symdeko®/Symkevi®).
• Clinical Research: Serves as a reference standard and raw material in ongoing clinical trials for expanded indications of CFTR modulators.
• Generic Drug Development: Key starting material for companies developing generic versions of ivacaftor upon patent expiry.
• Drug Product Manufacturing: Integrated into final dosage form production under strict Good Manufacturing Practice (GMP) conditions.

Basic Information

Product Name	Kalydeco Hydrate
CAS No.	1134822-07-3
Molecular Formula	C₂₄H₂₈N₃O₃ • xH₂O
Molecular Weight	392.50 (anhydrous basis)
Synonyms	Ivacaftor Hydrate; VX-770 Hydrate; N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide Hydrate; 5-hydroxy-2,4-di-tert-butyl-N-[4-oxo-1,4-dihydroquinoline-3-carbonyl]phenyl]benzamide Hydrate; Kalydeco (brand name); CFTR Potentiator Hydrate
EINECS	Contact for details

Quality Control

Our Kalydeco Hydrate is manufactured under a quality management system aligned with ICH Q7 guidelines for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing, including HPLC for assay and purity, determination of water content (Karl Fischer), and stringent control of related substances and residual solvents. A Certificate of Analysis (COA) is provided with each shipment, detailing compliance with agreed specifications. We support regulatory filings with DMF (Drug Master File) or CEP (Certificate of Suitability to the Monograph of the European Pharmacopoeia) documentation as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation or clumping.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Water Content (Karl Fischer)	As per typical hydrate form
Related Substances (HPLC)	Individual impurity: ≤0.15% Total impurities: ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	<20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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