This impurity is related to Irinotecan EP Impurity A is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Asenapine.
Irinotecan EP Impurity A is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(4S)-4-Ethyl-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 ;(S)-4-Ethyl-4-hydroxy-1H-pyrano[3?,4?:6,7]indolizino[1,2-b]quin oline-3,14(4H,12H)-dione-9-yl (1,4?-bipiperidine)-1?-carboxylate hydrochloride trihydrate (as per USP)Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Irinotecan Molecular Formula: C31H34N4O6 : HCl : 3(H2O)
Molecular Weight: 558.6 : 36.5 : 3(18.0)
Storage: Store in a cool, dry place.