Description

Epinastine Impurity 3 Dihcl is a high-purity chemical reference standard specifically identified for pharmaceutical quality control and research. This compound is critical for the accurate identification, quantification, and monitoring of related substances during the development and manufacturing of the antihistamine drug Epinastine. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable impurities to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance: For the identification and quantification of this specific impurity in Epinastine Active Pharmaceutical Ingredient (API) and finished drug products.
• Regulatory Compliance & Filing: Supporting regulatory submissions (e.g., to FDA, EMA) by providing impurity profiles and stability data.
• Research & Development: Used in pharmacokinetic, metabolic, and degradation pathway studies of Epinastine.
• Analytical Laboratory Calibration: Serves as a calibration standard for HPLC, UPLC, LC-MS, and other chromatographic systems.
• Stability Testing: Monitoring impurity levels in stability studies to determine shelf-life and storage conditions.

Basic Information

Product Name	Epinastine Impurity 3 Dihcl
CAS No.	339163-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinastine Related Compound 3; Epinastine Dihydrochloride Impurity 3; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine dihydrochloride; Epinastine Process Impurity; Epinastine Specified Impurity; (3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepin-1-yl)methanol dihydrochloride (related form); Epinastine Impurity C (Dihydrochloride)
EINECS	Contact for details

Quality Control

Every batch of Epinastine Impurity 3 Dihcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	< 20 ppm

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