Description

Hexamidine EP Impurity A HCl is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Hexamidine. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine quality control testing in accordance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Hexamidine EP Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis and purification processes.
• Quality Control & Assurance: Serves as a critical component in routine batch release testing to ensure drug substance and drug product specifications meet European Pharmacopoeia (EP), USP, or ICH guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., CMC sections) to agencies like the EMA and FDA, demonstrating control over the impurity profile.
• Research & Development: Used in pharmaceutical R&D to understand degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Hexamidine EP Impurity A HCl
CAS No.	104236-65-9
Molecular Formula	C20H28N4O2 • 2HCl
Molecular Weight	453.39 g/mol (for dihydrochloride salt)
Synonyms	1,6-Bis(4-amidinophenoxy)hexane dihydrochloride; Hexamidine Impurity A; Hexamidine Related Compound A; 4,4'-(Hexane-1,6-diylbis(oxy))dibenzimidamide dihydrochloride; 1,6-Di(4-amidinophenoxy)hexane dihydrochloride; Hexamidine Dihydrochloride Impurity A
EINECS	Contact for details

Quality Control

Every batch of Hexamidine EP Impurity A HCl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance 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). This material 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
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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