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Di Nitroso Venetoclax Impurity 2

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Katalog-Nr.::	VE0024250
CAS-Nr.::	N/A
Summenformel::	C45H48ClN9O9S
Molare Masse::	926.44 g/mol

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Zusätzliche Informationen zu Di Nitroso Venetoclax Impurity 2

Parent drug

Venetoclax

IUPAC-Name

2-((1H-pyrrolo[2, 3-b]pyridin-5-yl)oxy)-4-(4-((4′-chloro-5, 5-dimethyl-3, 4, 5, 6-tetrahydro-[1, 1′-biphenyl]-2-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-(nitroso((tetrahydro-2H-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-N-nitrosobenzamide

Pharmakopöe-Synonyme

N/A

Other Synonyms

N/A

SMILES

O=C(N(S(=O)(C1=CC=C(N(N=O)CC2CCOCC2)C([N+]([O-])=O)=C1)=O)N=O)C3=CC=C(N4CCN(CC5=C(C6=CC=C(Cl)C=C6)CC(C)(C)CC5)CC4)C=C3OC7=CN=C(NC=C8)C8=C7

InChI

InChI=1S/C45H48ClN9O9S/c1-45(2)15-11-33(39(26-45)31-3-5-34(46)6-4-31)29-51-17-19-52(20-18-51)35-7-9-38(42(24-35)64-36-23-32-12-16-47-43(32)48-27-36)44(56)54(50-58)65(61, 62)37-8-10-40(41(25-37)55(59)60)53(49-57)28-30-13-21-63-22-14-30/h3-10, 12, 16, 23-25, 27, 30H, 11, 13-15, 17-22, 26, 28-29H2, 1-2H3, (H, 47, 48)

Beschreibung

Di Nitroso Venetoclax Impurity 2 is an N-nitroso derivative of the secondary amine present in Venetoclax/ N-Nitroso | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Venetoclax/ N-Nitroso production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.