PHOTOLABILITY EVALUATION OF THE NEW CYTOSTATIC DRUG MITONAFIDE

A qualitative and quantitative study on the stability of the new cytos tatic drug mitonafide (N-[2-(dimethylamino)ethyl]-3-nitronaphthalimide , CAS 54824-17-8) against UV4, UVC and visible radiations was carried out. initially a test with controlled lighting on samples from mitonaf ide solution is carried out. This test include the determination of th e protector effect of different kinds of glasses (clear and amber glas s). The results achieved are verified by means of a test in normal lig hting conditions (direct sun light, normal laboratory lighting and dar kness). High mitonafide photodecomposition, deeper against UVA radiati on, requires conservation of raw, material in darkness. Similarly ster ilizing radiations must be avoided in sterile rooms during manufacture . The use of amber glass ampoules is not enough to protect parenteral solutions from radiations. Direct sunlight must be avoided in the manu facture, control tests and administration in perfusion of pharmaceutic al dosage forms, although artificial light cal? be used during short p eriods of time.