Category
Quinapril
CAS Number
NA
Molecular Formula
C₂₄H₂₉N₃O₄
Molecular Weight
423.51 g/mol
Synonym

(S)-Ethyl 2-(((S)-1-(3,4-dihydroisoquinolin-2(1H)-yl)-1-oxopropan-2-yl)(nitroso)amino)-4-phenylbutanoate; N-Nitroso Quinapril Decarboxy Impurity

Keywords
Pharmaceutical Standards
Impurities
Nitrosamine Standards
N-Nitrosamines Impurities manufacturers and Suppliers in Hyderabad India
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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 Quinapril Decarboxy Impurity is a nitrosamine-related decarboxylated degradation or process impurity associated with Quinapril. It can form when nitrosating agents react with amine-containing or decarboxylated intermediates during manufacturing or storage. This impurity is closely monitored in pharmaceutical quality control because nitrosamines are considered potentially mutagenic and are strictly controlled under regulatory guidelines to ensure the safety and purity of the final drug product.