Bortezomib Impurity 43

Novel method development and validation of bortezomib in bulk and pharmaceutical dosage form by RP-​HPLC
By Prasanna, Pasupuleti Laxmi; Sandhya, Pedapanga; Geetha, Pittala; Anuhya, Vallapatla M.
From Journal of Drug Delivery and Therapeutics (2019), 9(1), 17-22
 
Determination of bortezomib in API samples using HPLC: assessment of enantiomeric and diastereomeric impurities
By Kamalzadeh, Zahra; Babanezhad, Esmaeil; Ghaffari, Solmaz; Ezhiyeh, Alireza Mohseni; Mohammadnejad, Mahdieh; Naghibfar, Mehdi; Bararjanian, Morteza; Attar, Hossein
From Journal of Chromatographic Science (2017), 55(7), 697-705
 

Bortezomib Impurity 43 is chemically Pyrazine-2-carboxylic acid (1-[3-methyl-1-(2,9-dimethyl-3,5-dioxa-4-bora-tricyclo[6.1.1.0.2.6]dec-4-yl)-butylcarbamoyl]-2-phenyl-ethyl)-amide. Bortezomib Impurity 43 is supplied with detailed characterization data compliant with regulatory guideline. Bortezomib Impurity 43 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 Bortezomib.

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.