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Naphazoline Impurity 2 (Di HCl)

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Catalogue No.:	VE0017273
CAS No.:	N/A
Mol. Formula:	C14H17N3. 2 HCl
Mol. Weight:	227.31 2 36.46 g/mol

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Additional information on Naphazoline Impurity 2 (Di HCl)

Parent drug

Naphazoline

IUPAC Name

N-(2-aminoethyl)-2-(naphthalen-1-yl)acetimidamide, hydrochloride (1:2)

Synonyms

N/A

Description

Naphazoline Impurity 2 (Di HCl) is the dihydrochloride salt associated with an imidazoline vasoconstrictor impurity profile, formally described by formula C14H17N3.2HCl and molecular weight 227.31 2 36.46 g/mol. In process chemistry, such species may arise from incomplete cyclization, side-chain rearrangement, or salt-forming carryover during manufacture of naphazoline-related intermediates. Its protonated state can alter chromatographic retention and ionization behavior, requiring orthogonal characterization by LC-MS/MS, high-resolution MS, and, where necessary, ion-pair or hydrophilic interaction LC. Regulatory assessment focuses on structural assignment, impurity specification, and trace-level control rather than pharmacological activity, with confirmation supported by NMR and chloride content evaluation.