Description

Emedastine Impurity E is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Emedastine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Emedastine API and its formulations.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of Emedastine Impurity E in drug products under various stress conditions to determine shelf life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Emedastine.
• Pharmacopoeial Testing: Serves as a reference material for testing procedures outlined in pharmacopoeias such as USP or EP.

Basic Information

Product Name	Emedastine Impurity E
CAS No.	101954-20-5
Molecular Formula	C17H26N2O3
Molecular Weight	306.41 g/mol
Synonyms	1-(2-Ethoxyethyl)-2-(hexahydro-1H-azepin-4-yl)-1H-benzimidazole-6-carboxylic Acid; Emedastine Related Compound E; Emedastine EP Impurity E; Emedastine USP Impurity E; 1H-Benzimidazole-6-carboxylic acid, 1-(2-ethoxyethyl)-2-(hexahydro-1H-azepin-4-yl)-; UNII-6Y1Q4Q8V6P
EINECS	Contact for details

Quality Control

Every batch of Emedastine Impurity E is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We provide full traceability and Certificates of Analysis (COA) that include data from HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS). Our standards are suitable for use in regulatory submissions and comply with ICH Q3B (R2) guidelines on impurities in new drug products.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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