Imatinib mesylate

Category API

Details	Specifications
CAS Number	220127-57-1
Molecular Formula	C30H35N7O4S
Molecular Weight	589.71 g/mol.
Synonyms	Imatinib mesilate
Chemical Name	4-[(4-Methyl-1-piperazinyl) methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl] amino]-phenyl] benzamide methane sulfonate.
Common name	Imatinib mesylate
Therapeutic use	Chronic myelogenous leukemia (CML) and acute lymphocytic leukemia (ALL) that are Philadelphia chromosome–positive (Ph+), gastrointestinal stromal tumors (GIST), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), systemic mastocytosis, and myelodysplastic syndrome.
Background	Imatinib is used to treat [chronic myelogenous leukemia](https://en.wikipedia.org/wiki/Chronic_myelogenous_leukemia) (CML), [gastrointestinal stromal tumors](https://en.wikipedia.org/wiki/Gastrointestinal_stromal_tumor) (GISTs) and a number of other [malignancies](https://en.wikipedia.org/wiki/Malignancy). In 2006 the FDA expanded approved use to include [dermatofibrosarcoma protuberans](https://en.wikipedia.org/wiki/Dermatofibrosarcoma_protuberans) (DFSP), [myelodysplastic](https://en.wikipedia.org/wiki/Myelodysplastic_syndrome) / myeloproliferative diseases (MDS/MPD), and aggressive systemic [mastocytosis](https://en.wikipedia.org/wiki/Mastocytosis) (ASM)
Grade	EP & USP
Polymorph	Alfa Non-needle, Needle & Beta form
GTI	Risk assessment report available
Nitrosamines	Risk assessment report available
DMF Availability	USDMF# 28349, R1 - CEP-2016 - 121 - Rev 01
Manufacturing batch size	130.0 Kg
Production capacity	Annual capacity is 12 – 15 tonnes
Stability data	Available

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