Hydroxy Donepezil (Mixture of diastereomers)

Hydroxy Donepezil (Mixture of diastereomers) is chemically 2-[(1-Benzylpiperidin-4-yl)(hydroxy)methyl]-5,6-dimethoxyindan-1-one ; . It is also known as Donepezil Hydroxy Keto Impurity ; . Hydroxy Donepezil (Mixture of diastereomers) is supplied with detailed characterization data compliant with regulatory guideline. Hydroxy Donepezil (Mixture of diastereomers) 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.

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

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• The quotation ID needs to be mentioned in the purchase order.
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Delivery time:

• In Stock product will dispatch in 24 h after receipt of purchase order. It usually take 2-3 days to receive products in India and 5-6 working days for export customer depending on destination.
• The custom synthesis products would be dispatched as per quoted timeline.

Shipping:

• There will be 100 USD towards logistic charges per shipment if we used our FedEx. There will not be any charge if we use your FedEx/DHL Account. Depending on part shipment logistic charges will be added.
• For countries dispatch by courier is not allowed where product would be dispatched in cargo mode as per agreed Inco term.

Additional Charges:

• Controlled substance charges need to follow as per quotation. The specific inputs are required for controlled substance because regulatory status will differ based on destination.
• Cold Shipment Charges needs to be considered as per quotation.
• For ice pack there are no additional charges.

Technical Queries:

• All technical queries need to raise within 15 days of product receipt. Thereafter it will be our resolved at our discretion.

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• All communication will be addressed to standards@synzeal.com
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  • For New products # standards@synzeal.com
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