Hyoscine Butylbromide EP Impurity D

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Catalogue No.:	VL78001
CAS No.:	N/A
Mol. Formula:	C20H28NO4
Mol. Weight:	346.45 g/mol

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Additional information on Hyoscine Butylbromide EP Impurity D

Parent drug

Hyoscine Butylbromide

IUPAC Name

(1R,2R,4S,5S,7s,9r)-7-[[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy]-9-methyl-9-propyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane

Synonyms

Hyoscine Propyl Impurity

Smiles

CCC[N@@+]1(C)[C@@]2([H])[C@@]3([H])O[C@@]3([H])[C@]1([H])C[C@H](OC([C@@H](C4=CC=CC=C4)CO)=O)C2

InChI

InChI=1S/C20H28NO4/c1-3-9-21(2)16-10-14(11-17(21)19-18(16)25-19)24-20(23)15(12-22)13-7-5-4-6-8-13/h4-8,14-19,22H,3,9-12H2,1-2H3/q+1/t14-,15-,16-,17+,18-,19+,21+/m1/s1

Description

Hyoscine Butylbromide EP Impurity D, also designated Hyoscine Propyl Impurity, is a defined structural analogue of the tropane ester antimuscarinic scaffold, consistent with alkyl homologation at the quaternary ammonium side chain. With molecular formula C20H28NO4 and molecular weight 346.45 g/mol, it is generally interpreted as a process-related impurity arising from alkylation or incomplete cationic chain-transfer during synthesis of the butylbromide derivative. Its characterization requires LC-MS/MS and high-resolution LC-HRMS, with NMR confirmation when reference elucidation is needed. As a non-nitrosamine impurity, it is not classed under ICH M7 genotoxic alerts, but remains relevant for impurity profiling and pharmacopeial specification control.