acetylisovaleryltylosin tartrate and its Impurities

Acetylisovaleryltylosin, used as the tartrate salt, is a new macrolide antibiotic which is active against Gram-positive bacteria. It is proposed as an aid in the prevention and treatment of Swine (Mycoplasma) Enzootic Pneumonia (Swine Epidemic Pneumonia) caused by sensitive organism. Reference standards of Acetylisovaleryltylosin Tartrate API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.