Irinotecan Hydrochloride Trihydrate

Category API

Details	Specifications
CAS Number	136572-09-3
Molecular Formula	C33H38N4O6.HCl.3H2O
Molecular Weight	677.18 g/mol.
Synonyms	(S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate hydrochloride trihydrate.
Chemical Name	[(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diaza pentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15 (20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate;hydrate; hydrochloride
Common name	Irinotecan hydrochloride trihydrate
Therapeutic use	Irinotecan anticancer drug, irinotecan was various cancers such as lung, cervical and ovarian cancer. Used to treat colorectal cancer and pancreatic adenocarcinoma.
Background	Irinotecan is a topoisomerase inhibitor used to treat metastatic carcinoma of the colon or rectum and pancreatic adenocarcinoma. It is a water-soluble analogue of Camptothecin, which is extracted from the Chinese tree Camptothecin acuminate
Grade	EP and USP
Polymorph	Trihydrate form
GTI	Risk assessment report available
Nitrosamines	Risk assessment report available
DMF Availability	USDMF# 23562, R1 - CEP-2017 - 147 - Rev 00
Manufacturing batch size	6.0 kg
Production capacity	Annual capacity 800 – 900 kg
Stability data	Available

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