Category
Adagrasib
CAS Number
NA
Molecular Formula
C₂₄H₃₆N₈O₄
Molecular Weight
500.59 g/mol
Synonym

(S)-Tert-butyl 2-(cyanomethyl)-4-(2-(((S)-1-methylpyrrolidin-2-yl)methoxy)-7-nitroso-5,6,7,8-tetrahydropyrido[3,4-d]pyrimidin-4-yl)piperazine-1-carboxylate ; Adagrasib Nitroso Impurity-1

Keywords
Impurities
Aromatics
Nitrosamine
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.

Adagrasib Nitroso Impurity-1 is a potential nitrosamine-type impurity that can form during the synthesis or storage of Adagrasib, typically arising from reactions involving amine groups and nitrosating agents; such impurities are closely monitored and controlled at very low levels due to their potential carcinogenic risk according to regulatory guidelines.