Isolation and characterization of process-related impurities and degradation products in larotaxel.

The isolation and characterization of the process related impurities and degradation products of larotaxel drug substance were described. Forced degradation of larotaxel was carried out under acidic, basic, oxidation, light and thermal conditions to assess the nature of the impurities. The pure impurities were obtained by semi-preparative LC isolation and analyzed by NMR and MS. The structures of impurities were confirmed as 7,8-cyclopropyl baccatin III, 10-deacetyl larotaxel, 10-deacetyl-7, 8-cyclopropyl baccatin III, 7-acetyl-8-methyl larotaxel and 2',13-bissidechain larotaxel.