Description

Azelastine Impurity 7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antihistamine drug Azelastine by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, API production, and regulatory affairs. The material is supplied with comprehensive analytical data to support method validation and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Azelastine Hydrochloride API and finished drug products.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing of Azelastine batches to monitor impurity levels and ensure they remain within specified pharmacopeial limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to characterize the impurity profile of the drug substance.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to understand and control impurity formation during API synthesis.

Basic Information

Product Name	Azelastine Impurity 7
CAS No.	791758-74-2
Molecular Formula	C22H24ClN3O
Molecular Weight	381.90 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; Desmethyl Azelastine Impurity; Azelastine Related Compound 7; Azelastine EP Impurity G; Azelastine USP Impurity; 1(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(1-methyl-4-azepanyl)-; UNII-9J3S35A4QH
EINECS	Contact for details

Quality Control

Every batch of Azelastine Impurity 7 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture content. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results and chromatographic data. Our quality standards align with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
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.