Erythromycin EP Impurity B

Isolation and identification of a novel erythromycin-​degrading fungus, Curvularia sp. RJJ-​5, and its degradation pathway
By Ren, Jianjun; Deng, Liujie; Niu, Dongze; Wang, Zhenzhu; Fan, Bo; Taoli, Huhe; Li, Zhijie; Zhang, Jin; Li, Chunyu
From FEMS Microbiology Letters (2021), 368(1), fnaa215.
 
Development and validation of a stability indicating HPLC method for organic impurities of erythromycin stearate tablets
By Jeelani, Salika; Soukhova, Nadejda
From Journal of Pharmaceutical and Biomedical Analysis (2021), 195, 113858
 
Degradation and mineralization of erythromycin by heterogeneous photocatalysis using SnO2-​doped TiO2 structured catalysts: Activity and stability
By Albornoz, L. L.; da Silva, S. W.; Bortolozzi, J. P.; Banus, E. D.; Brussino, P.; Ulla, M. A.; Bernardes, A. M.
From Chemosphere (2021), 268, 128858
 

Erythromycin EP Impurity B is chemically (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (as per EP); (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-Ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-6-{[(2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (as per USP). It is also known as Erythromycin USP Related Compound N ; 3″-N-Desmethylerythromycin A (EP) ; N-Demethylerythromycin A. Erythromycin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin 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 Erythromycin.

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.