Bosentan Impurity 15

Research and Development of a Second-Generation Process for Bosentan, an Endothelin Receptor Antagonist
Peter J. Harrington, Hiralal N. Khatri, Brad S. DeHoff, Martin R. Guinn, Mark A. Boehler, and Karl A. Glaser
Organic Process Research & Development 2002, 6, 120−124
 
Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate: An Endothelin Receptor Antagonist
Sanjay A. Jadhav,1 Shashikant B. Landge,1 Sonali L. Jadhav,1 Navanath C. Niphade,1 Saroj R. Bembalkar,2 and Vijayavitthal T. Mathad1
E-Hindawi Access to Research Chromatography Research International Volume 2011, Article ID 929876, 9 pages
 
Development and validation of a stability indicating analytical method for the related substances of Bosentan drug substance by HPLC
Mubeen Ahmad Khan, Sukumar Sinha, Mangesh Todkar, Vikas Parashar, K. Swamy Reddy
Am. J. Sci. Ind. Res., 2012, 3(2): 69-80

Bosentan Impurity 15 is chemically Pyrimidine-2-carboximidamide hydrochloride. Bosentan Impurity 15 is supplied with detailed characterization data compliant with regulatory guideline. Bosentan Impurity 15 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 Bosentan.

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.