The stability of the amorphous form of cefuroxime axetil in solid state.

The stability of the amorphous form of cefuroxime axetil was studied by means of the stress stability test. The degradation was evaluated using the HPLC method with UV detection (278 nm), as described in the monograph of Cefuroxime Axetil in European Pharmacopoeia. Liquid chromatography was performed with a H5 SAS Hypersil column (5 microm particle size, 250 mmx4 mm), the mobile phase consisted of a mixture of 38 volumes of methanol and 62 volumes of a 23 g l-1 solution of ammonium dihydrogen phosphate, a flow rate of 1.

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.