Description

Epinastine Ep Impurity A is a high-purity reference standard critical for analytical method development and validation in pharmaceutical manufacturing. This compound serves as a key impurity marker for Epinastine, an antihistamine drug substance, ensuring product safety and regulatory compliance. It is essential for quality control laboratories in the pharmaceutical and biotechnology sectors, particularly for those involved in the research, development, and production of ophthalmic and systemic allergy medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Epinastine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during drug synthesis and purification processes.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to ensure Epinastine APIs and formulations meet stringent pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in stability testing of Epinastine drug substances and products.
• Process Chemistry Research: Aids chemists in optimizing synthesis routes by identifying and controlling the formation of this specific impurity.

Basic Information

Product Name	Epinastine Ep Impurity A
CAS No.	706753-75-5
Molecular Formula	C16H15N3O
Molecular Weight	265.31 g/mol
Synonyms	Epinastine Impurity A; Epinastine Related Compound A; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepin-1-one; (13bS)-3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepin-1-one; Epinastine EP Impurity A; Epinastine USP Impurity A; WAL 801 CL Impurity A
EINECS	Contact for details

Quality Control

Every batch of Epinastine Ep Impurity A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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