Description

Hexamidine Impurity 4 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of the active pharmaceutical ingredient Hexamidine, a widely used antiseptic and preservative agent. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers requiring precise impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Hexamidine in drug substances and finished products.
• Method Development and Validation (HPLC/GC): Crucial for developing, calibrating, and validating chromatographic methods to quantify impurity levels.
• Quality Control and Assurance (QC/QA): Used in-house by API manufacturers to monitor and control the impurity profile during production to meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track the formation of this specific degradation product in Hexamidine formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for Hexamidine.

Basic Information

Product Name	Hexamidine Impurity 4
CAS No.	74065-84-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Hexamidine Related Compound 4; Hexamidine Impurity D; Hexamidine EP Impurity D; Hexamidine USP Impurity; 1,6-Bis(4-amidinophenoxy)hexane Impurity; 4,4'-(Hexane-1,6-diylbis(oxy))dibenzimidamide Impurity; Hexamidine Isomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Hexamidine Impurity 4 is produced and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

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