N - (4 - (2,2 Dimethyl propiomil) - (5R) - 5 - (2 - amino - etanosulfonil ethylamino) - methyl - 5 - phenyl - 4,5-dihydro - 1,3,4 thiadiazole - il - 2} - 2,2-dimethyl propionamide

摘要

1. A pharmaceutical ingredient characterized by the presence of {4 - (2,2-dimethyl-propyl) ester - (5R) - 5 - [(2-ethylamine-acetylfluoro-toluidamide) - methyl] - 5-phenyl-4,5-dihydro - [1,3,4] thiazol-2-il} - 2,2-dimethyl-propylamide, a scarf and / or salt selected from tartrato, phosphate, citrate, methyl ester, phosphate, sodium sulfate and a vehicle,The pH value of solution or pre solution in dilute aqueous solution is less than 5.4 and more than 2.0%, and it contains not more than 2.0% {4 - (2,2-dimethyl-propyl) - 5 - [(2-ethylamine-ethane-acetamide) - methyl] - 5-fenil-4.5-dihydro - [1,3,4] endosulfan-2-il} - 2, 2-dimethylpropionamide, a pharmaceutical ingredient stable for artificial transformation of Industrial Zone 2. - 1, wherein scarves and / or salts are selected in tar, phosphate, Sodium citrate, sodium phosphate, 3. - pharmaceutical ingredients of Industrial Zone 2, in which scarf and / or salt are selected between tar and sodium phosphate 4. - pharmaceutical ingredients of industrial zone 3, scarf and / or salt are tar.