Description

Emedastine Ep Impurity C Hcl CAS NO 122423-32-9 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the antihistamine drug Emedastine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in research and development, method validation, and routine batch analysis within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Emedastine Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a critical system suitability component in the routine quality control testing of Emedastine to ensure batch-to-batch consistency and purity.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies such as the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Emedastine Ep Impurity C Hcl
CAS No.	122423-32-9
Molecular Formula	C17H26ClN3O3 • HCl
Molecular Weight	392.33 g/mol (for HCl salt)
Synonyms	Emedastine Impurity C; Emedastine Related Compound C; 1-(2-Ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)-1H-benzimidazole Ep Impurity C Hydrochloride; UNII-7K7K3J4V3Q; 1H-Benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)-, hydrochloride (1:?); Emedastine Dihydrochloride Impurity C; Emedastine EP Impurity C
EINECS	Contact for details

Quality Control

Our Emedastine Ep Impurity C Hcl is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results against stringent in-house specifications aligned with pharmacopeial standards. Our commitment to traceability and data integrity supports your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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