Description

Zafirlukast Impurity G is a specified, structurally characterized impurity of the active pharmaceutical ingredient Zafirlukast, a leukotriene receptor antagonist used in asthma treatment. This high-purity reference standard is critical for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. It is essential for quality control laboratories, research institutions, and API producers focused on ensuring the safety and efficacy of Zafirlukast-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zafirlukast Impurity G in drug substances and products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods as per ICH Q2(R1) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., ANDA, NDA, CMC sections) by providing impurity profile data required by FDA, EMA, and other global health authorities.
• Stability Studies: Used to monitor impurity levels in forced degradation and long-term stability studies of Zafirlukast to establish shelf-life.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in routine QC testing of API and finished dosage forms.
• Research & Impurity Profiling: Aids in synthetic route optimization and impurity fate and tolerance studies during process development.

Basic Information

Product Name	Zafirlukast Impurity G
CAS No.	1391990-94-5
Molecular Formula	C31H33N3O6S
Molecular Weight	575.68 g/mol
Synonyms	Zafirlukast Related Compound G; 5-[[(1-Carboxy-1-methylethoxy)carbonyl]amino]-1-[[[3-[(4-methoxyphenyl)methyl]-2-thienyl]methyl]thio]methyl]-1H-indole-3-acetic acid; Accolate Impurity G; ICI-204,219 Impurity G; Zafirlukast EP Impurity G; Zafirlukast USP Impurity G; (Zafirlukast Carboxy Impurity)
EINECS	Contact for details

Quality Control

Our Zafirlukast Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, related substances, residual solvents, and spectroscopic identification (IR, NMR, MS). Quality standards align with current pharmacopeial expectations (USP, EP) for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.