Description

Epinastine Impurity 10 is a designated impurity standard of the antihistamine drug Epinastine, identified by CAS No. 41218-85-3. This high-purity reference material is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories and pharmaceutical manufacturers for research, method development, and rigorous quality control testing. The compound is essential for impurity profiling, stability studies, and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Epinastine Impurity 10 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance (QC/QA): A critical component in routine QC testing to ensure Epinastine drug substances and products meet specified purity limits as per ICH Q3A/B guidelines.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development (R&D): Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Epinastine.

Basic Information

Item	Details
Product Name	Epinastine Impurity 10
CAS No.	41218-85-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinastine Related Compound; Epinastine Impurity; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine; 1H-Dibenz[c,f]imidazo[1,5-a]azepine, 3-amino-9,13b-dihydro-; Potential process-related impurity of Epinastine
EINECS	Contact for details

Quality Control

Our Epinastine Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability. We support compliance with ICH guidelines and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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

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