N-Nitroso Bupropion 3,4-Dichloro Impurity
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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

N-Nitroso Bupropion 3,4-Dichloro Impurity

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Catalogue No.:VE0024576
CAS No.:N/A
Mol. Formula:C13H16Cl2N2O2
Mol. Weight:303.18 g/mol

Additional information on N-Nitroso Bupropion 3 | 4-Dichloro Impurity

Parent drug

Bupropion

IUPAC Name

N-(tert-butyl)-N-(1-(3, 4-dichlorophenyl)-1-oxopropan-2-yl)nitrous amide

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=NN(C(C)(C)C)C(C)C(C1=CC=C(Cl)C(Cl)=C1)=O

InChI

InChI=1S/C13H16Cl2N2O2/c1-8(17(16-19)13(2, 3)4)12(18)9-5-6-10(14)11(15)7-9/h5-8H, 1-4H3

Description

N-Nitroso Bupropion 3 | 4-Dichloro Impurity is an N-nitroso derivative of the secondary amine present in Bupropion | 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 Bupropion 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.

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