Spiramycin EP Impurity B

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-a-l-ribo-hexopyranosyl)-3-(dimethylamino)-?d-glucopyranosyl]oxy]-4-hydroxy-7-(2-hydroxyethyl)-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-?d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one (spiramycin IV).

Country of Origin: India

Product Category: Spiramycin Impurities

Spiramycin EP Impurity B is identified by CAS No. 249930-66-3 and is chemically known as (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-a-l-ribo-hexopyranosyl)-3-(dimethylamino)-?d-glucopyranosyl]oxy]-4-hydroxy-7-(2-hydroxyethyl)-5-methoxy-9,16-dimethyl-10-[[2,3,4,6-tetradeoxy-4-(dimethylamino)-?d-erythro-hexopyranosyl]oxy]oxacyclohexadeca-11,13-dien-2-one (spiramycin IV).

Spiramycin EP Impurity B 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 Spiramycin.

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