Description

Chlorhexidene Diacetate Impurity C is a specified impurity of the broad-spectrum antimicrobial agent Chlorhexidine Diacetate. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of final drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a reference standard in impurity profiling and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Chlorhexidine Diacetate impurities in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance purity meets pharmacopeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data.
• Research & Development (R&D): Facilitates research into the degradation pathways and chemical stability of Chlorhexidine-based formulations.

Basic Information

Product Name	Chlorhexidene Diacetate Impurity C
CAS No.	62247-48-7
Molecular Formula	C26H38Cl2N10O4
Molecular Weight	625.56 g/mol
Synonyms	1,1'-Hexamethylenebis[5-(4-chlorophenyl)biguanide] Diacetate Impurity C; Chlorhexidine Diacetate Related Compound C; N,N''''-Bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide Diacetate Impurity; Chlorhexidine Impurity C; Biguanide derivative impurity; Antibacterial agent impurity; Pharmaceutical impurity standard
EINECS	Contact for details

Quality Control

Every batch of Chlorhexidene Diacetate Impurity C 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 they meet the high standards required for 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 at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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