Donepezil Nitroso Impurity 1

New gradient high-performance liquid chromatography method for determination of donepezil hydrochloride assay and impurities content in oral pharmaceutical formulation
Stella Kafkala ∗, Stella Matthaiou, Pandora Alexaki, Morfis Abatzis, Antonios Bartzeliotis, Maria Katsiabani
Journal of Chromatography A, 1189 (2008) 392–397
 
Identification and characterization of potential impurities of donepezil
K.V.S.R. Krishna Reddy a, J. Moses Babu a, P. Anil Kumar b, E.R.R. Chandrashekar b, Vijayavitthal T. Mathad b, S. Eswaraiah b, M. Satyanarayana Reddy b, K. Vyas
Journal of Pharmaceutical and Biomedical Analysis 35 (2004) 1047–1058
 
An Improved and Efficient Process for the Production of Donepezil Hydrochloride: Substitution of Sodium Hydroxide for n-Butyl Lithium via Phase Transfer Catalysis
Navanath Niphade, Anil Mali, Kunal Jagtap, Ramesh Chandra Ojha, Pravinchandra J. Vankawala, and Vijayavitthal T. Mathad
Organic Process Research & Development 2008, 12, 731–735
 
Analytical Method Development and Validation for the Analysis of Donepezil Hydrochloride and Its Related Substances Using Ultra Perfomance Liquid Chromatography
Mahalingam V* , Kalaivani R A, Somanathan T, Vijayabaskar S
International Journal of Pharmaceutical and Clinical Research 2017; 9(5): 417-424

Donepezil Nitroso Impurity 1 is chemically 5,6-Dimethoxy-2-((1-nitrosopiperidin-4-yl)methyl)-1H-inden-1-ol. Donepezil Nitroso Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Donepezil Nitroso Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Donepezil.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.