Category
Umeclidinium
Nitrosamine Impurities
CAS Number
1038-06-8
Molecular Formula
C₁₈H₂₀N₂O₂
Molecular Weight
296.37 g/mol
Synonym

(1-nitrosopiperidin-4-yl)-diphenylmethanol; 1-Nitroso-4-(α-hydroxy-benzhydryl)-piperidin; 
N-Nitroso Fexofenadine EP Impurity E

Keywords
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Nitrosamine Standards
Nitrosamine Standards manufacturers and Suppliers in Hyderabad India
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 Azacyclonol is a nitrosamine impurity related to Azacyclonol that may form during pharmaceutical synthesis or storage in the presence of nitrosating agents. Nitrosamine impurities are closely monitored because prolonged exposure above acceptable limits may pose potential carcinogenic risks. Therefore, sensitive analytical techniques such as HPLC and LC-MS are used to detect and control N-Nitroso Azacyclonol in pharmaceutical materials and formulations.