Hydroxychloroquine Sulfate EP Impurity B

Identification and characterization of process related impurities in chloroquine and hydroxychloroquine by LC​/IT​/MS, LC​/TOF​/MS and NMR
By Dongre, Vaijanath G.; Ghugare, Pradeep D.; Karmuse, Pravin; Singh, Dharmendra; Jadhav, Atul; Kumar, Ashok
From Journal of Pharmaceutical and Biomedical Analysis (2009), 49(4), 873-879
 
Analytical and semi-​preparative high-​performance liquid chromatographic separation and assay of hydroxychloroquine enantiomers
By Brocks, Dion R.; Pasutto, Franco M.; Jamali, Fakhreddin
From Journal of Chromatography, Biomedical Applications (1992), 581(1), 83-92
 
Estimation of plasma hydroxychloroquine by high-​performance liquid chromatography with ultraviolet detection
By Morris, Raymond G.
From Journal of Chromatography, Biomedical Applications (1985), 338(2), 422-7
 

Hydroxychloroquine Sulfate EP Impurity B is chemically 2-[[(4RS)-4-[(7-Chloroquinolin-4-yl)amino]pentyl](ethyl)amino]ethyl hydrogen sulfate (as per EP); 2-({4-[(7-Chloroquinolin-4-yl)amino]pentyl}ethylamino)ethyl hydrogen sulfate (as per USP). It is also known as Hydroxychloroquine O-Sulfate. Hydroxychloroquine Sulfate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Hydroxychloroquine Sulfate EP Impurity B 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 Hydroxychloroquine.

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.