Description

Chlorhexidene Diacetate Impurity A is a high-purity chemical reference standard, specifically identified as an impurity of the broad-spectrum antimicrobial agent Chlorhexidine Diacetate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of final drug products. It is an essential material for research scientists, analytical chemists, and quality assurance professionals in the pharmaceutical and fine chemical industries.

Application

• Primary use as a certified reference standard (CRS) for the quantitative and qualitative analysis of Chlorhexidine Diacetate.
• Critical component in pharmaceutical impurity profiling and method validation for regulatory submissions (e.g., ICH guidelines).
• Used in HPLC, GC, and LC-MS system suitability testing and calibration.
• Supports research and development of analytical procedures for antiseptic and disinfectant formulations containing chlorhexidine.
• Essential for stability studies to monitor degradation pathways of Chlorhexidine Diacetate API.
• Employed in pharmacopoeial testing (USP, EP, BP) to ensure compliance with monograph specifications.

Basic Information

Product Name	Chlorhexidene Diacetate Impurity A
CAS No.	152504-08-0
Molecular Formula	C26H38Cl2N10O4
Molecular Weight	625.56 g/mol
Synonyms	1,1'-Hexamethylenebis[5-(4-chlorophenyl)biguanide] Diacetate Impurity A; Chlorhexidine Diacetate Related Compound A; N,N''''-Bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide Diacetate Impurity; Chlorhexidine Impurity A; Biguanide derivative impurity; Antibacterial agent impurity; Antiseptic degradation product; Pharmaceutical impurity standard
EINECS	Contact for details

Quality Control

Every batch of Chlorhexidene Diacetate Impurity A is manufactured and controlled under a strict quality management system. The material is characterized and qualified using advanced analytical techniques including NMR, Mass Spectrometry, and HPLC to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches CRS
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0 - 102.0%

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