Description

Azelastine Impurity As-03 CAS NO 169123-29-9 is a specified impurity of the antihistamine drug Azelastine Hydrochloride, used for quality control and analytical reference purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azelastine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure drug substance and product meet pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Item	Details
Product Name	Azelastine Impurity As-03
CAS No.	169123-29-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one; Azelastine Related Compound As-03; Azelastine Impurity C; Azelastine EP Impurity C; Azelastine USP Related Compound C; 1(2H)-Phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(1-methyl-4-azepanyl)-; Azelastine Process Impurity
EINECS	Contact for details

Quality Control

Our Azelastine Impurity As-03 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for use as a pharmaceutical reference standard in regulated environments.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture. For long-term storage, consider desiccants or storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.