TI: Role of residual solvents in the formation of
volatile compounds after radiosterilisation of cefotaxime.
AU: Barbarin,-N; Rollmann,-B; Tilquin,-B
SO: Int-J-Pharm. 1999 Feb 15; 178(2): 203-12
IS: 0378-5173
LA: English
AB: Radiation sterilisation is a promising method to sterilise
pharmaceutical products. However, this process is accompanied by a modification
of odour due to volatile compounds formation. The origin of malodorous
compounds produced during solid cefotaxime radiosterilisation has been
investigated and several mechanisms are proposed to explain their appearance.
Moreover, some quantitative data are given. Analysis of the degradation
products was performed using a GC-ITD system with an injection by the static
headspace technique. It appeared that some of the radio-induced compounds
(such as carbon oxide sulfide and carbon disulfide) came from the degradation
of the drug itself, whereas the formation of others required the presence
of residual solvents which are volatile impurities already present before
irradiation. Acetaldehyde directly came from impurities but the appearance
of esters and acetaldehyde O-methyloxime was due to the presence of both
cefotaxime and residual solvents together. Thus, the residual solvents
play a key role in the radiolysis compounds formation (six of eight require
the presence of them) and consequently in the modification of odour as
well.