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Description

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 (as per EP);
(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)

Synonym: 11-Desethyl Irinotecan (as per EP)

Shipping Temperature:
Ambient

HSN Code:
38229010

Country of Origin: India

Smiles: O[C@@](C(OC1)=O)(CC)C2=C1C(N3C(C4=NC5=CC=C(OC(N6CCC(N7CCCCC7)CC6)=O)C=C5C=C4C3)=C2)=O.[3H2O].Cl

Additional Information

Irinotecan EP Impurity A is chemically (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 (as per EP);
(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)
.
It is also known as 11-Desethyl Irinotecan (as per EP).
Irinotecan EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Irinotecan EP 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 Irinotecan.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

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