Sunitinib Malate

Category API

Details	Specifications
CAS Number	341031-54-7
Molecular Formula	C22H27FN4O2 .C4H6O5
Molecular Weight	532.56 g/mol.
Synonyms	N-[2-(diethylamino) ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene) methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide ;(2S)-2-hydroxy butane dioic acid
Chemical Name	N-[2-(diethylamino) ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide ;(2S)-2-hydroxy butane dioic acid
Common name	Sunitinib
Therapeutic use	Sunitinib is a receptor tyrosine kinase inhibitor and chemotherapeutic agent used for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST).
Background	Sunitinib malate (marketed under the brand name Sutent by Pfizer) is an orally administered, multitargeted receptor tyrosine kinase (RTK) inhibitor with potent anti-tumor and anti-angiogenic activities. It was first approved by the US FDA in January 2006, making it a pioneer in targeted cancer
Grade	In-house
Polymorph	Form-I
GTI	Risk assessment report available
Nitrosamines	Risk assessment report available
DMF Availability	USDMF# 33085, ASMF# EU / ASMF / 00359 / 0001
Manufacturing batch size	13.0 Kg
Production capacity	Annual capacity is 1.0 - 1.2 tonnes
Stability data	Available

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