Josamycin EP Impurity I

Josamycin EP Impurity I is chemically (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-Dideoxy-4-O-(2,6-dideoxy-3-C-methyl-4-O-propanoyl-α-L-ribo-hexopyranosyl)-3-(dimethylamino)-β-D-glucopyranosyl]oxy]-4,10-dihydroxy-5-methoxy-9,16-dimethyl-7-(2-oxoethyl)oxacyclohexadeca-11,13-dien-2-one (as per EP). Josamycin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Josamycin EP Impurity I 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 Josamycin.

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.