N-Nitroso Diltiazem EP Impurity G

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Catalogue No.:	VE0024814
CAS No.:	N/A
Mol. Formula:	C19H21N3O4S
Mol. Weight:	387.5 g/mol

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Additional information on N-Nitroso Diltiazem EP Impurity G

Parent drug

N-Nitroso/ Diltiazem

IUPAC Name

N-(2-((2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)-4-oxo-3,4-dihydrobenzo[b][1,4]thiazepin-5(2H)-yl)ethyl)-N-methylnitrous amide

Pharmacopoeial Synonyms

N/A

Other Synonyms

N-Nitroso O-Desacetyl-N-desmethyl Diltiazem

Smiles

O[C@@H]1[C@H](C2=CC=C(OC)C=C2)SC3=CC=CC=C3N(CCN(N=O)C)C1=O

InChI

InChI=1S/C19H21N3O4S/c1-21(20-25)11-12-22-15-5-3-4-6-16(15)27-18(17(23)19(22)24)13-7-9-14(26-2)10-8-13/h3-10, 17-18, 23H, 11-12H2, 1-2H3/t17-, 18+/m1/s1

Description

N-Nitroso Diltiazem EP Impurity G, also designated N-Nitroso O-Desacetyl-N-desmethyl Diltiazem, is a nitrosamine-related process impurity of the benzothiazepine calcium-channel blocker diltiazem. With molecular formula C19H21N3O4S and molecular weight 387.5 g/mol, it represents an N-nitrosated derivative arising plausibly from nitrosative conditions during synthesis, workup, or storage of desmethylated and deacetylated intermediates. As a class, nitrosamines are treated as potential genotoxic impurities under ICH M7 due to structural alerts and carcinogenic concern. Trace-level characterization commonly requires LC-MS/MS, high-resolution mass spectrometry, and, where volatility permits, GC-MS with selective derivatization.