Irinotecan EP Impurity A

RP-​HPLC method development and validation for the simultaneous estimation of Irinotecan hydrochloride and Capecitabine in Active Pharmaceutical Ingredients (APIs)
By Vijaya Jyothi, M.; Bhargav, E.; Keerthana, B.; Varalakshmi, Devi K.
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2018), 9(1), 63-67
 
Method development, validation and forced degradation studies of Irinotecan in bulk and pharmaceutical dosage form
By Swathi, Koduru; Farooqui, Tahmeena; Muntaha, Sidra Tul; Ayesha, Syeda Amtul; Shama, Syeda; Siddiqui, Sarah Imam
From World Journal of Pharmacy and Pharmaceutical Sciences (2018), 7(8), 996-1009
 

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. SynZeal products are for analytical purpose only and not for human use.