Description

Zafirlukast Impurity 17 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the asthma medication Zafirlukast, ensuring the safety and efficacy of the final drug product. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory testing laboratories to identify, quantify, and monitor this specific impurity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zafirlukast Impurity 17 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to ensure Zafirlukast API and finished drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Zafirlukast Impurity 17
CAS No.	1160235-28-8
Molecular Formula	C31H33N3O6S
Molecular Weight	575.68 g/mol
Synonyms	N-[4-[(5-Cyclopentyloxy-2-hydroxy-3-[(2-methoxy-4-[[(phenylsulfonyl)amino]carbonyl]benzoyl)amino]phenyl]methyl]phenyl]methanesulfonamide; Zafirlukast Related Compound 17; Zafirlukast EP Impurity 17; Zafirlukast USP Impurity 17; Accolate Impurity 17; ZD-9188 Impurity; (2-Hydroxy-3-[[2-methoxy-4-[(phenylsulfonyl)carbamoyl]benzoyl]amino]-5-cyclopentyloxybenzyl)-N-(methylsulfonyl)aniline
EINECS	Contact for details

Quality Control

Every batch of Zafirlukast Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. Desiccants are recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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