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152504-10-4Chlorhexidine EP Impurity N

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Catalogue No.:	VE009301
CAS No.:	152504-10-4
Mol. Formula:	C15H25ClN8
Mol. Weight:	352.87 g/mol

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Additional information on CAS 152504-10-4

Parent drug

Chlorhexidine

IUPAC Name

1-[6-(Carbamimidoylamino)hexyl]-5-(4-chlorophenyl)biguanide

Synonyms

Chlorhexidine guanidine

Description

Chlorhexidine EP Impurity N, also termed chlorhexidine guanidine, is a basic diguanide-related process impurity associated with chlorhexidine manufacturing or oxidative and hydrolytic transformation of the biguanide framework. CAS 152504-10-4; molecular formula C15H25ClN8; molecular weight 352.87 g/mol. The structure retains the cationic chlorophenyl biguanide motif, supporting strong ionization and chromatographic tailing on conventional reversed-phase systems. Quantification generally requires LC-MS/MS or LC-HRMS, with occasional ion-pair LC or HILIC optimization and confirmatory NMR for structural assignment. As a specified pharmacopoeial impurity, it is evaluated within impurity profiling and impurity qualification frameworks rather than as a simple degradation marker.

References

Lim, K. -S ., and P. C. A. Kam. â€œChlorhexidine – Pharmacology and Clinical Applications.â€ Anaesthesia and Intensive Care, vol. 36, no. 4, July 2008, pp. 502â€“12, https://doi.org/10.1177/0310057×0803600404. â€Œ