Midostaurin Impurity D

Impurity profiling and stability-​indicating method development and validation for the estimation of assay and degradation impurities of midostaurin in softgel capsules using HPLC and LC-​MS
By Lakka, Narasimha Swamy; Kuppan, Chandrasekar; Ravinathan, Poornima
From Biomedical Chromatography (2021), Ahead of Print.

RP-​HPLC method development and validation for the estimation of midostaurin in bulk and pharmaceutical dosage form
By Harikrishnan, Narayanaswamy; Subramanian, Gejalakshmi; Hemalatha, C. N.; Pavankumar, V.
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2020), 11(4), 5108-5112

Impurity profiling and stability-​indicating method development and validation for the estimation of assay and degradation impurities of midostaurin in softgel capsules using HPLC and LC-​MS
By Lakka Narasimha Swamy; Kuppan Chandrasekar; Ravinathan Poornima
From Biomedical chromatography : BMC (2021), e5222

Midostaurin Impurity D is chemically (5S,6R,7R,9R)-7-((benzoyloxy)(methyl)amino)-6-methoxy-5-methyl-6,7,8,9,15,16-hexahydro-5H,14H-17-oxa-4b,9a,15-triaza-5,9-methanodibenzo[b,h]cyclonona[jkl]cyclopenta[e]-as-indacen-14-one. It is also known as Midostaurin N-Benzoyloxy impurity. Midostaurin Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Midostaurin Impurity D 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 Midostaurin.

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.