Description

Zafirlukast M6 Metabolite is a key reference standard and analytical intermediate in pharmaceutical research and development. This compound is critical for conducting accurate pharmacokinetic and metabolic studies of the asthma medication Zafirlukast, ensuring drug safety and efficacy. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in drug metabolism and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Zafirlukast and its metabolites in biological matrices.
• Metabolite Identification & Profiling: Essential for in-vitro and in-vivo studies to map the metabolic pathways of Zafirlukast.
• Impurity Characterization: Serves as a known impurity standard for method development and validation in drug substance and product quality control.
• Bioanalytical Assay Development: Critical for developing and validating HPLC, LC-MS, and other analytical methods to measure metabolite levels in pharmacokinetic studies.
• Drug Safety & Toxicology Studies: Employed to assess the potential biological activity and toxicity of this specific metabolite.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding of a drug's metabolic fate.

Basic Information

Product Name	Zafirlukast M6 Metabolite
CAS No.	219582-85-1
Molecular Formula	C31H33N3O6S
Molecular Weight	575.68 g/mol
Synonyms	Zafirlukast Carboxylic Acid Metabolite; Zafirlukast Metabolite M6; 4-[[(5-Cyclopentyloxy-2-hydroxy-3-[(2-methylphenyl)thio]phenyl)methyl]-3-methoxy-N-[(4-methylphenyl)sulfonyl]benzamide; 3-[[[3-[(2-Methylphenyl)thio]-2-[(tetrahydro-2H-pyran-2-yloxy)carbonyl]phenyl]methyl]-4-(methylsulfonyl)benzoic Acid (related precursor); Accolate Metabolite; ICI-204,219 Metabolite
EINECS	Contact for details

Quality Control

Our Zafirlukast M6 Metabolite is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for demanding analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant industry guidelines for reference standards, supporting compliance in GLP and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at -20°C under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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