Description

Chlorhexidine Impurity B CAS NO 1308292-89-8 is a high-purity chemical reference standard, specifically identified as a key impurity of the widely used antiseptic agent Chlorhexidine. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug development and manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on ensuring the safety, efficacy, and regulatory compliance of Chlorhexidine-based products.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of Chlorhexidine Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent purity specifications per ICH Q3A/B guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Used to monitor the formation and level of this specific impurity over time under various storage conditions.
• Research and Development: Supports synthetic route optimization and degradation studies to understand impurity formation pathways.

Basic Information

Product Name	Chlorhexidine Impurity B
CAS No.	1308292-89-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-Hexamethylenebis[5-(4-chlorophenyl)biguanide] Impurity B; Chlorhexidine Related Compound B; N'-(4-Chlorophenyl)-N''-{6-[N'-(4-chlorophenyl)carbamimidamido]hexyl}carbamimidamide; Chlorhexidine Digluconate Impurity B; CHG Impurity B
EINECS	Contact for details

Quality Control

Every batch of Chlorhexidine Impurity B is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (e.g., HPLC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

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

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