Description

Chlorhexidine Digluconate Impurity N is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Chlorhexidine Digluconate, a widely used antiseptic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Chlorhexidine Digluconate API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure impurity levels remain within specified limits (ICH guidelines).
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Compliance & Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development (R&D): Used in chemical and pharmaceutical R&D to study the degradation pathways and synthesis by-products of Chlorhexidine Digluconate.

Basic Information

Item	Details
Product Name	Chlorhexidine Digluconate Impurity N
CAS No.	152504-10-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-Hexamethylenebis[5-(p-chlorophenyl)biguanide] Digluconate Impurity N; Chlorhexidine Gluconate Impurity N; Chlorhexidine Digluconate Related Compound N; N,N''-Bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide Digluconate Impurity; CHG Impurity N; Biguanide Impurity; Process-Related Impurity of Chlorhexidine Gluconate
EINECS	Contact for details

Quality Control

Every batch of Chlorhexidine Digluconate Impurity N is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (IR)	Conforms to Reference Standard
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 Guidelines
Water Content (KF)	≤ 5.0%

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