The stability of Cefuroxime axetil in tablets.

The stability of cefuroxime axetil in BIORACEF tablets was studied by means of long term (298 K/60% RH), intermediate (303 K/65% RH), accelerated (313 K/75% RH) and stress stability tests. Changes in the concentration of cefuroxime axetil diastereoisomers A and B and their total was determined using the RP-HPLC method, as described in a monograph of Cefuroxime axetil tablets in the British Pharmacopoeia 2003. After 2 years of storage under long term, 1 year under intermediate and 6 months under accelerated storage conditions, the preparation of BIORACEF meets the quality requirements as regards both.