Description

Chlorhexidine Digluconate Impurity K is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in Chlorhexidine Digluconate. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing the widely used antiseptic agent Chlorhexidine. It is an essential material for analytical laboratories, quality control departments, and research institutions in the pharmaceutical and fine chemical industries focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference standard for the identification, method development, and validation of analytical procedures (e.g., HPLC, LC-MS) to monitor and control this specific impurity in Chlorhexidine Digluconate Active Pharmaceutical Ingredient (API) and finished drug products.
• Quality Assurance & Regulatory Compliance: Essential for creating impurity specifications and supporting regulatory filings (e.g., with FDA, EMA) by providing definitive proof of structure and purity for this known impurity.
• Stability Studies and Forced Degradation: Used as a marker to track the formation of Chlorhexidine Digluconate Impurity K under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life and storage recommendations.
• Research and Development: A vital tool for R&D chemists studying the degradation pathways, synthesis by-products, and overall chemistry of Chlorhexidine and its derivatives.
• Calibration and System Suitability: Employed to calibrate analytical instruments and perform system suitability tests to ensure the accuracy and precision of impurity testing methods.

Basic Information

Product Name	Chlorhexidine Digluconate Impurity K
CAS No.	1381962-77-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-Hexamethylenebis[5-(p-chlorophenyl)biguanide] Digluconate Related Compound K; Chlorhexidine Gluconate Impurity K; Chlorhexidine Digluconate Related Substance K; Chlorhexidine Impurity K (Gluconate); Biguanide derivative impurity of Chlorhexidine Gluconate
EINECS	Contact for details

Quality Control

Our Chlorhexidine Digluconate Impurity K is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization, including HPLC for purity assessment and spectroscopic techniques (NMR, MS) for structural confirmation, to ensure it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data on identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material carefully to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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