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N-Nitroso N-Desethyl Amiodarone EP Impurity C

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Katalog-Nr.::	VE0024758
CAS-Nr.::	N/A
Summenformel::	C23H25IN2O4
Molare Masse::	520.37 g/mol

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Zusätzliche Informationen zu N-Nitroso N-Desethyl Amiodarone EP Impurity C

Parent drug

Amiodarone

IUPAC-Name

N-(2-(4-(2-Butylbenzofuran-3-carbonyl)-2-iodophenoxy)ethyl)-N-ethylnitrous amide

Pharmakopöe-Synonyme

N/A

Other Synonyms

N/A

SMILES

O=NN(CCOC1=CC=C(C(C2=C(CCCC)OC3=CC=CC=C23)=O)C=C1I)CC

InChI

InChI=1S/C23H25IN2O4/c1-3-5-9-21-22(17-8-6-7-10-19(17)30-21)23(27)16-11-12-20(18(24)15-16)29-14-13-26(4-2)25-28/h6-8, 10-12, 15H, 3-5, 9, 13-14H2, 1-2H3

Beschreibung

N-Nitroso N-Desethyl Amiodarone EP Impurity C is an N-nitroso derivative of the secondary amine present in Amiodarone/ 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 Amiodarone/ 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.