Sugammadex Monohydroxy Impurity

Analytical method development and validation for the estimation of sugammadex
By Parekh, Hemangi; Chokshi, Parin; Mashru, Rajashree
From Journal of Drug Delivery and Therapeutics (2020), 10(1), 52-59.
 
Determination of sugammadex in human plasma, urine, and dialysate using a high-performance liquid chromatography/tandem mass spectrometry assay
By de Zwart Marcel A H; ten Bruggencate-Broeders Jolanda; van Hal Henk J M; Megens Rene H J J J; Frasa Helma W L H
From Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (2011), 879(19), 1573-86.
 

Sugammadex Monohydroxy Impurity is chemically 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-y-Cyclodextrin. Sugammadex Monohydroxy Impurity is supplied with detailed characterization data compliant with regulatory guideline. Sugammadex Monohydroxy Impurity 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 Sugammadex.

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.