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N-Nitroso Tadalafil
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| Catalogue No.: | VE0015849 |
|---|---|
| CAS No.: | N/A |
| Mol. Formula: | C22H18N4O5 |
| Mol. Weight: | 418.41 g/mol |
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Additional information on N-Nitroso Tadalafil
Parent drug
TadalafilIUPAC Name
(6R,12aR)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-7-nitroso-2,3,12,12a-tetrahydropyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4(6H,7H)-dioneSmiles
O=C([C@@]1([H])CC2=C([C@@H](C3=CC=C(OCO4)C4=C3)N15)N(N=O)C6=C2C=CC=C6)N(C)CC5=OInChI
InChI=1S/C22H18N4O5/c1-24-10-19(27)25-16(22(24)28)9-14-13-4-2-3-5-15(13)26(23-29)21(14)20(25)12-6-7-17-18(8-12)31-11-30-17/h2-8,16,20H,9-11H2,1H3/t16-,20-/m1/s1Pharmacopeial Synonyms
N/AOther Synonyms
N/ADescription
N-Nitroso Tadalafil is a nitrosamine-related impurity derived from tadalafil, with molecular formula C22H18N4O5 and molecular weight 418.41 g/mol. This structural class is of heightened regulatory concern because N-nitrosamines are frequently associated with mutagenic and potentially carcinogenic risk, placing such species within the scope of ICH M7 considerations. Formation may occur through nitrosating conditions during synthesis or storage when secondary amine functionality is exposed to nitrite sources. Structural confirmation and trace-level quantification typically require orthogonal high-sensitivity methods, including LC-MS/MS, HRMS, and, where appropriate, GC-MS with selective ion monitoring.Request a Quote
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