Description

Zafirlukast Impurity – D is a specified, structurally characterized impurity used in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Zafirlukast. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and adherence to stringent pharmacopeial guidelines. It is primarily utilized in the development, validation, and routine testing of analytical methods for Zafirlukast, serving as a key reference standard in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Zafirlukast API and its finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Zafirlukast batches meet specified impurity limits as per ICH Q3A/B guidelines and regulatory submissions.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during the Zafirlukast manufacturing process.

Basic Information

Product Name	Zafirlukast Impurity – D
CAS No.	1160235-24-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zafirlukast Related Compound D; Zafirlukast Impurity D; Zafirlukast EP Impurity D; Zafirlukast USP Impurity D; 5-(2-Methoxy-4-{[(2-methylphenyl)sulfonyl]carbamoyl}phenyl)-1,3,4-oxadiazol-2(3H)-one; Accolate Impurity D; ICI-204,219 Impurity D
EINECS	Contact for details

Quality Control

Our Zafirlukast Impurity – D is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH guidelines and relevant pharmacopeial standards (USP, EP).

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. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to ensure stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.