This impurity is related to Risedronate EP Impurity A (Disodium Tetrahydrate) 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.
Risedronate EP Impurity A (Disodium Tetrahydrate) is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:[(2?,3?,5?,6?)-2,5-dihydroxy-2,5-dioxo-3,6-bis[(pyridin-3-yl)methyl]-1,4,2?5,5?5-dioxadiphosphinane-3,6-diyl]bis(phosphonic acid) disodium tetrahydrate (as per EP) ; [3,6-Bis[(3-pyridinyl)methyl]-2,5-dihydroxy-2,5-dioxido-1,4,2,5-dioxadiphosphorinane3,6-diyl]bis[phosphonic acid] disodium tetrahydrate salt (as per USP)Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Risedronic Acid Molecular Formula: C14H16N2O12P4 : 2(Na) : 4(H2O)
Molecular Weight: 528.2 : 2(23.0) : 4(18.0)
Storage: Store in a cool, dry place.