Description

Hydroxy Tipelukast-D6 is a deuterated isotopologue of a key pharmaceutical intermediate, specifically designed for use as an internal standard in quantitative mass spectrometry. This high-purity compound is essential for ensuring analytical accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers involved in drug development and bioanalysis.

Application

• Primary use as a deuterated internal standard for the quantification of Tipelukast and its metabolites in biological matrices via LC-MS/MS.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to ensure precise and accurate measurement of drug concentrations.
• Supporting drug metabolism and disposition (DMPK) research for investigating the metabolic pathways of leukotriene receptor antagonists.
• Enabling high-quality analytical method development and validation in compliance with FDA and ICH guidelines.
• Used in clinical trial sample analysis to monitor drug levels and ensure patient safety and study integrity.
• Application in impurity profiling and characterization of active pharmaceutical ingredients (APIs) during manufacturing.

Basic Information

Product Name	Hydroxy Tipelukast-D6
CAS No.	1027597-04-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tipelukast D6 hydroxy analog; Deuterated Tipelukast metabolite; [D6]-Hydroxy Tipelukast; Tipelukast-d6 hydroxylated derivative; Internal standard for Tipelukast LC-MS; Leukotriene receptor antagonist deuterated standard; Isotopically labeled Tipelukast metabolite
EINECS	Contact for details

Quality Control

Every batch of Hydroxy Tipelukast-D6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure exceptional isotopic purity and chemical identity. Our quality assurance protocols are designed to meet the stringent requirements of analytical reference standard applications. A comprehensive Certificate of Analysis (COA) detailing isotopic enrichment (D6), chemical purity by HPLC, and confirmatory spectroscopy (NMR, MS) is provided with each shipment to support your regulatory submissions and quality documentation.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D6)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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