Description

Epinastine Impurity 1 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical development and manufacturing of the antihistamine Epinastine. It is primarily required by analytical laboratories, quality assurance departments, and research institutions involved in method development, impurity profiling, and stability studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Epinastine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection and characterization.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability testing protocols.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Epinastine.

Basic Information

Item	Detail
Product Name	Epinastine Impurity 1 Hcl
CAS No.	141342-71-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinastine Related Compound A; Epinastine Impurity A; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine Hydrochloride; (3aS,13bR)-3-Amino-2,3,3a,13b-tetrahydro-1H-dibenz[c,f]imidazo[1,5-a]azepine Hydrochloride; Epinastine HCl Impurity 1; Epinastine Hydrochloride Impurity 1
EINECS	Contact for details

Quality Control

Our Epinastine Impurity 1 Hcl is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (CoA) detailing all test results and traceability is provided with every shipment.

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 must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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