Midostaurin Impurity A

Midostaurin Impurity A is chemically 6,7,12,13-Tetrahydro-5H-Indolo[2,3-a]pyrrolo[3,4-c]carbazol-5-one. It is also known as K252c ; Staurosporine aglycon ; Staurosporinone. Midostaurin Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Midostaurin Impurity A 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.

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

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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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