abstract |
REFERRING TO A PROCESS FOR THE ELABORATION OF TIGECYCLINE AS A RECONSTITUTABLE POWDER THAT HAS LESS THAN 0.9% TOTAL DEGRADANTS, WHERE SUCH PROCESS INCLUDES: a) REDUCE AND MAINTAIN THE LEVEL OF OXYGEN IN WATER FOR LESS INJECTION (W OR LESS) AT 0.5 ppm, KEEPING THE TEMPERATURE BETWEEN 2ºC AND 8ºC, b) FORM A TIGECYCLINE SOLUTION IN SAID WATER FROM THE PREVIOUS PASSAGE AT A CONCENTRATION OF BETWEEN 10 TO 50 MG / ML, KEEPING THE TEMPERATURE AND OXYGEN LEVEL, c) FILLING THE BOTTLES WITH THE FORMED SOLUTION, d) FREEZE THE STEP C SOLUTION FORMING 25 MG TO 150 MG OF RECONSTITUTABLE POWDER IN A BOTTLE AND e) SEAL THE BOTTLE UNDER NITROGEN. SAID PREPARATION OF TIGECYCLINE IS FOR INJECTIONS |