Description

Azelastine Ep Impurity E CAS NO 105279-16-1 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Azelastine Hydrochloride. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by professionals in pharmaceutical R&D, analytical method development, and regulatory compliance for the production of antihistamine medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Azelastine Hydrochloride API.
• Essential for analytical method development and validation (HPLC, GC) in quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles.
• Critical for regulatory submissions (e.g., ANDA, NDA) to meet ICH Q3A/B guidelines on impurities.
• Supports pharmaceutical research into the synthesis pathways and degradation mechanisms of Azelastine.
• Employed as a calibration standard in high-precision analytical instrumentation.

Basic Information

Product Name	Azelastine Ep Impurity E
CAS No.	105279-16-1
Molecular Formula	C22H24ClN3O
Molecular Weight	381.90 g/mol
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; Azelastine Impurity E; Azelastine Related Compound E; Azelastine EP Impurity E; 1(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(1-methyl-4-azepanyl)-; UNII-8H5QWM4VEJ; Azelastine Hydrochloride Impurity E
EINECS	Contact for details

Quality Control

Every batch of Azelastine Ep Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (EP, USP). Comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), is performed. Certificates of Analysis (COA) with detailed chromatographic data are available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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