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86-30-6N-Nitroso-diphenylamine (NDPhA)

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Nº do catálogo:	VE006106
Nº CAS:	86-30-6
Fórmula Mol.::	C12H10N2O
Peso Mol.::	198.22

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Informações adicionais sobre o CAS 86-30-6

Fármaco de origem

N/A

Nome IUPAC

N-Nitrosodiphenylamine

SMILES

O=NN(C1=CC=CC=C1)C2=CC=CC=C2

InChI

InChI=1S/C12H10N2O/c15-13-14(11-7-3-1-4-8-11)12-9-5-2-6-10-12/h1-10H

Condição de envio

Ambient Temperature

Pharmacopeial Synonyms

N/A

Sinônimos

Diphenylnitrosamine; Nitrosodiphenylamine; N-Nitroso-N-phenylaniline; N,N-Diphenylnitrosamine; N-Nitroso-N-phenylbenzenamine; N,N’-diphenylnitrous hydrazide

FDA Potency Category 1 NDSRI

26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N‑Nitrosodiphenylamine (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Sinônimos farmacopeicos

N/A

Outros sinônimos

Diphenylnitrosamine; Nitrosodiphenylamine; N-Nitroso-N-phenylaniline; N,N-Diphenylnitrosamine; N-Nitroso-N-phenylbenzenamine; N,N’-diphenylnitrous hydrazide

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Dados adicionais de caracterização

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Descrição

N-Nitrosodiphenylamine is an N-nitroso derivative of the secondary amine, 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 API and raw material 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.

Referências

Li, Zhigang, et al. ?Molecularly Imprinted Solid Phase Extraction Coupled with Gas Chromatography-Mass Spectrometry for Determination of N-Nitrosodiphenylamine in Water Samples.? Chemosphere, vol. 212, Dec. 2018, pp. 872?80, https://doi.org/10.1016/j.chemosphere.2018.08.159.?