Description

Ivacaftor-D19 is a deuterated isotopologue of the cystic fibrosis transmembrane conductance regulator (CFTR) potentiator Ivacaftor, where nineteen hydrogen atoms are replaced with deuterium. This strategic deuteration is designed to potentially alter the pharmacokinetic profile, such as metabolic stability, which is of significant interest in advanced pharmaceutical research and development. It serves as a critical reference standard and intermediate for researchers and manufacturers in the pharmaceutical industry, particularly those focused on developing and validating deuterated drug substances for improved therapeutic outcomes.

Application

• Pharmaceutical Reference Standard: Used as an analytical standard for the identification, purity assessment, and quantification of deuterated Ivacaftor in research and quality control laboratories.
• Metabolic Studies: Employed in preclinical and clinical research to investigate the absorption, distribution, metabolism, and excretion (ADME) profiles of deuterated drug candidates.
• Deuterated Drug Development: Serves as a key intermediate or final active pharmaceutical ingredient (API) in the synthesis of deuterium-enriched versions of Ivacaftor aimed at enhancing drug efficacy and safety.
• Isotope Labeling Research: Utilized in mechanistic studies and tracer experiments to understand biological pathways and drug-receptor interactions using mass spectrometry and NMR techniques.
• Regulatory Submissions: Provides essential material for the preparation of documentation required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Ivacaftor-D19
CAS No.	1413431-22-7
Molecular Formula	C24H19D19N2O3
Molecular Weight	407.60 g/mol (approximate)
Synonyms	N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide-D19; VX-770-D19; Kalydeco-D19; (R)-1-(2,4-Di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid-D19; Deuterated Ivacaftor; Ivacaftor (deuterated); CFTR Potentiator D19
EINECS	Contact for details

Quality Control

Our Ivacaftor-D19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, NMR and MS for structural confirmation and deuterium enrichment, and tests for residual solvents and impurities to ensure it meets high-grade standards suitable for research and development. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting all critical quality attributes.

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 should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Deuterium Enrichment (NMR/MS)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines
Heavy Metals	< 20 ppm

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