Category
Enalapril
Nitrosamine Impurities
CAS Number
2994317-06-3
Molecular Formula
C₂₀H₂₇N₃O₆
Molecular Weight
405.45 g/mol
Synonym

N-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanyl-L-proline.(Rotamers) ; N-((S)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanylproline ; (S)-1-((S)-2-(((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)(nitroso)amino)propanoyl)pyrrolidine-2-carboxylic acid; N-Nitroso Enalapril (Rotamers) ; Enalapril N-Nitroso (Rotamers)

Keywords
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Nitrosamine Standards
slide.1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

N-Nitroso Enalapril is a nitrosamine impurity of Enalapril. Nitrosamines can form during synthesis or storage under certain conditions and are classified as potentially carcinogenic. Regulatory agencies require strict monitoring and control of N-nitroso enalapril levels to ensure the safety and quality of the drug.