Melphalan Impurity 16

Determination of melphalan by micelle enhanced spectrofluorimetric method: application to content uniformity testing and human plasma
By Sambhani, Naga Gayatri; Biju, Valsala Madhavan Nair
From Tenside, Surfactants, Detergents (2020), 57(1), 40-44
 
Rapid and simple flow injection analysis tandem mass spectrometric method for the quantification of melphalan in a lipid-​based drug delivery system
By Mohammed-Saeid, Waleed; Michel, Deborah; Badea, Ildiko; El-Aneed, Anas
From Rapid Communications in Mass Spectrometry (2017), 31(18), 1481-1490

Melphalan Impurity 16 is chemically (R)-Methyl-2-(tert-butoxycarbonylamino)-3-(4-nitrophenyl)propanoate. Melphalan Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Melphalan Impurity 16 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 Melphalan.

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.