Chlorhexidine Diacetate EP Impurity B

Identification and Isolation of Chlorhexidine Digluconate Impurities
Larry K. Revelle, William H. Doub, Roger T. Wilson, Monica H. Harris & Aaron M. Rutter
Pharmaceutical Research volume 10, pages1777–1784(1993)
 
Assay of stability, free and total concentration of chlorhexidine in saliva by solid phase microextraction
Florin Marcel Musteata, Janusz Pawliszyn
Journal of Pharmaceutical and Biomedical Analysis 37 (2005) 1015–1024
 
Liquid Chromatography‑Tandem Mass Spectrometry Determination of p‑Chloroaniline in Gel and Aqueous Chlorhexidine Products Used in Dentistry
Antônio Rubens Gonçalves1 · Heliara Lopes do Nascimento2 · Gustavo H. B. Duarte2 · Rosineide C. Simas2 · Adriana de Jesus Soares3 · Marcos Nogueira Eberlin2 · Lygia Azevedo Marques
Chromatographia (2016) 79:841–849

Chlorhexidine Diacetate EP Impurity B is chemically N-[N-[6-[[N-[N-(4-chlorophenyl)carbamimidoyl]carbamimidoyl]amino]hexyl]carbamimidoyl]urea (as per EP) ; N-{[6-({[(4-Chlorophenyl)carbamimidoyl]carbamimidoyl}amino)hexyl]carbamimidoyl}urea (as per USP). It is also known as Chlorhexidine Urea (USP). Chlorhexidine Diacetate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Chlorhexidine Diacetate EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Chlorhexidine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.